DEPUY CMW 1G 40G

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4) INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED: "IT WAS REPORTED THAT PATIENT WAS PRESENT IN THE OPERATING ROOM FOR AN INVERTED TOTAL SHOULDER REPLACEMENT. DURING THE CEMENTING OF THE HUMERAL STEM, THE CEMENT DOES NOT ADHERE TO THE STEM OR THE BONE. THE CEMENTED STEM WAS SMOOTH, AND THE HUMERAL SHAFT WAS WELL DRIED. THE CEMENT SHEATH HAD COME OFF IN ONE PIECE. ((B)(4) RECORDED FOR THE FIRST PATIENT). A SECOND PATIENT PRESENTED THE SAME ISSUE WITH THE SAME CEMENT AND LOT, BUT THE STEMS WERE NOT THE SAME. ((B)(4) RECORDED FOR THE SECOND PATIENT). EXTENSION OF THE PROCEDURE. ACTIONS WERE TAKEN FOR THE PATIENT REGARDING THE DEVICE: COMPLETELY REMOVED CEMENT, RE-CEMENTING OF THE STEM WITH A CEMENT FROM A DIFFERENT LOT. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION REVEALED THE DEVICE PACKAGE UNOPENED. DEVICE WAS SENT TO THE MANUFACTURER FOR FURTHER ANALYSIS. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE DEPUY CMW 1G 40G: THE SAMPLES WERE TESTED IN A TEMPERATURE AND HUMIDITY-CONTROLLED LABORATORY. TEST REVEALED THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE AND MET THE APPROPRIATE CONTROL SPECIFICATION. A FOLLOW UP WAS PERFORMED TO THE CUSTOMER TO PROVIDE FURTHER INVESTIGATION ON THE CEMENT/MIX DETAILS DURING SURGERY, HOWEVER NO ANSWER WAS NOTIFIED. GIVEN THE CURRENTLY INFORMATION AND EVIDENCE PROVIDED (PHOTO), THE REPORTED ALLEGATION CAN BE CONFIRMED AS THE CUSTOMER MAY HAD EXPERIENCED CONSISTENCY ISSUES WITH THE CEMENT BUT CANNOT BE TRACED TO MANUFACTURING. THE MODE OF FAILURE OF THE DEVICE IS MULTI-FACTORIAL AND CONSIDERATION MUST BE GIVEN TO ALL OTHER POTENTIAL INFLUENCES SUCH AS CEMENT MIX AND SET TIME PROCESS, STORAGE AND OR TEMPERATURE, OR OTHER STEP DURING THE SURGICAL PROCESS. ANY CONCLUSIONS FROM THE INVESTIGATIONAL INPUT PROVIDED HAVE TO BE PLACED INTO CONTEXT WITH ALL OTHER RELEVANT FACTORS. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4200143 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4200143 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. CORRECTED: H3.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4) INVESTIGATION SUMMARY ACCORDING TO THE INFORMATION PROVIDED: "IT WAS REPORTED THAT PATIENT WAS PRESENT IN THE OPERATING ROOM FOR AN INVERTED TOTAL SHOULDER REPLACEMENT. DURING THE CEMENTING OF THE HUMERAL STEM, THE CEMENT DOES NOT ADHERE TO THE STEM OR THE BONE. THE CEMENTED STEM WAS SMOOTH, AND THE HUMERAL SHAFT WAS WELL DRIED. THE CEMENT SHEATH HAD COME OFF IN ONE PIECE. (B)(4) RECORDED FOR THE FIRST PATIENT). A SECOND PATIENT PRESENTED THE SAME ISSUE WITH THE SAME CEMENT AND LOT, BUT THE STEMS WERE NOT THE SAME. (B)(4) RECORDED FOR THE SECOND PATIENT). EXTENSION OF THE PROCEDURE. ACTIONS WERE TAKEN FOR THE PATIENT REGARDING THE DEVICE: COMPLETELY REMOVED CEMENT, RE-CEMENTING OF THE STEM WITH A CEMENT FROM A DIFFERENT LOT. PHOTOS ATTACHED". THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES; HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT (PHOTOS OSIRIS CIMENT DEPUY). THE PHOTO INVESTIGATION REVEALED THE CEMENT MIX SHAPED AS THE STEM/IMPLANT. NO OTHER ANOMALY WAS NOTED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. A RETAIN SAMPLE TEST WAS PERFORMED FOR THE DEPUY CMW 1G 40G. THE SAMPLES WERE TESTED IN A TEMPERATURE AND HUMIDITY-CONTROLLED LABORATORY. TEST REVEALED THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE AND MET THE APPROPRIATE CONTROL SPECIFICATION. A FOLLOW UP WAS PERFORMED TO THE CUSTOMER TO PROVIDE FURTHER INVESTIGATION ON THE CEMENT/MIX DETAILS DURING SURGERY; HOWEVER, NO ANSWER WAS NOTIFIED. GIVEN THE CURRENTLY INFORMATION AND EVIDENCE PROVIDED, THE REPORTED ALLEGATION CAN BE CONFIRMED AS THE CUSTOMER MAY HAD EXPERIENCED CONSISTENCY ISSUES WITH THE CEMENT BUT CANNOT BE TRACED TO MANUFACTURING. THE MODE OF FAILURE OF THE DEVICE IS MULTI-FACTORIAL AND CONSIDERATION MUST BE GIVEN TO ALL OTHER POTENTIAL INFLUENCES SUCH AS CEMENT MIX AND SET TIME PROCESS, STORAGE AND OR TEMPERATURE, OR OTHER STEP DURING THE SURGICAL PROCESS. ANY CONCLUSIONS FROM THE INVESTIGATIONAL INPUT PROVIDED HAVE TO BE PLACED INTO CONTEXT WITH ALL OTHER RELEVANT FACTORS. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4200143 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE DEPUY CMW 1G 40G WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4200143 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. ADDED: G4 PMA/ 510(K), H6 HEALTH EFFECT - IMPACT CODE CORRECTED: D2B, H6 MEDICAL DEVICE PROBLEM CODE.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ACCORDING TO THE INFORMATION PROVIDED: "IT WAS REPORTED THAT PATIENT WAS PRESENT IN THE OPERATING ROOM FOR AN INVERTED TOTAL SHOULDER REPLACEMENT. DURING THE CEMENTING OF THE HUMERAL STEM, THE CEMENT DOES NOT ADHERE TO THE STEM OR THE BONE. THE CEMENTED STEM WAS SMOOTH, AND THE HUMERAL SHAFT WAS WELL DRIED. THE CEMENT SHEATH HAD COME OFF IN ONE PIECE. (B)(4) RECORDED FOR THE FIRST PATIENT). A SECOND PATIENT PRESENTED THE SAME ISSUE WITH THE SAME CEMENT AND LOT, BUT THE STEMS WERE NOT THE SAME. (B)(4) RECORDED FOR THE SECOND PATIENT). EXTENSION OF THE PROCEDURE. ACTIONS WERE TAKEN FOR THE PATIENT REGARDING THE DEVICE: COMPLETELY REMOVED CEMENT, RE-CEMENTING OF THE STEM WITH A CEMENT FROM A DIFFERENT LOT. PHOTOS ATTACHED". ¿THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT (PHOTOS OSIRIS CIMENT DEPUY). THE PHOTO INVESTIGATION REVEALED THE CEMENT MIX SHAPED AS THE STEM/IMPLANT. NO OTHER ANOMALY WAS NOTED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. A RETAIN SAMPLE TEST WAS PERFORMED FOR THE DEPUY CMW 1G 40G. THE SAMPLES WERE TESTED IN A TEMPERATURE AND HUMIDITY-CONTROLLED LABORATORY. TEST REVEALED THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE AND MET THE APPROPRIATE CONTROL SPECIFICATION. A FOLLOW UP WAS PERFORMED TO THE CUSTOMER TO PROVIDE FURTHER INVESTIGATION ON THE CEMENT/MIX DETAILS DURING SURGERY, HOWEVER NO ANSWER WAS NOTIFIED. GIVEN THE CURRENTLY INFORMATION AND EVIDENCE PROVIDED, THE REPORTED ALLEGATION CAN BE CONFIRMED AS THE CUSTOMER MAY HAD EXPERIENCED CONSISTENCY ISSUES WITH THE CEMENT BUT CANNOT BE TRACED TO MANUFACTURING. THE MODE OF FAILURE OF THE DEVICE IS MULTI-FACTORIAL AND CONSIDERATION MUST BE GIVEN TO ALL OTHER POTENTIAL INFLUENCES SUCH AS CEMENT MIX AND SET TIME PROCESS, STORAGE AND OR TEMPERATURE, OR OTHER STEP DURING THE SURGICAL PROCESS. ANY CONCLUSIONS FROM THE INVESTIGATIONAL INPUT PROVIDED HAVE TO BE PLACED INTO CONTEXT WITH ALL OTHER RELEVANT FACTORS. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4200143 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE DEPUY CMW 1G 40G WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE.¿ BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4200143 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT WAS PRESENT IN THE OPERATING ROOM FOR AN INVERTED TOTAL SHOULDER REPLACEMENT. DURING THE CEMENTING OF THE HUMERAL STEM, THE CEMENT DOES NOT ADHERE TO THE STEM OR THE BONE. THE CEMENTED STEM WAS SMOOTH, AND THE HUMERAL SHAFT WAS WELL DRIED. THE CEMENT SHEATH HAD COME OFF IN ONE PIECE. (B)(4) RECORDED FOR THE FIRST PATIENT) A SECOND PATIENT PRESENTED THE SAME ISSUE WITH THE SAME CEMENT AND LOT, BUT THE STEMS WERE NOT THE SAME. (B)(4) RECORDED FOR THE SECOND PATIENT) EXTENSION OF THE PROCEDURE. ACTIONS WERE TAKEN FOR THE PATIENT REGARDING THE DEVICE: COMPLETELY REMOVED CEMENT, RE-CEMENTING OF THE STEM WITH A CEMENT FROM A DIFFERENT LOT.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ACCORDING TO THE INFORMATION PROVIDED: "IT WAS REPORTED THAT PATIENT WAS PRESENT IN THE OPERATING ROOM FOR AN INVERTED TOTAL SHOULDER REPLACEMENT. DURING THE CEMENTING OF THE HUMERAL STEM, THE CEMENT DOES NOT ADHERE TO THE STEM OR THE BONE. THE CEMENTED STEM WAS SMOOTH, AND THE HUMERAL SHAFT WAS WELL DRIED. THE CEMENT SHEATH HAD COME OFF IN ONE PIECE. (B)(4) RECORDED FOR THE FIRST PATIENT). A SECOND PATIENT PRESENTED THE SAME ISSUE WITH THE SAME CEMENT AND LOT, BUT THE STEMS WERE NOT THE SAME. ((B)(4) RECORDED FOR THE SECOND PATIENT). EXTENSION OF THE PROCEDURE. ACTIONS WERE TAKEN FOR THE PATIENT REGARDING THE DEVICE: COMPLETELY REMOVED CEMENT, RE-CEMENTING OF THE STEM WITH A CEMENT FROM A DIFFERENT LOT. PHOTOS ATTACHED". THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION REVEALED THE DEVICE PACKAGE UNOPENED. DEVICE WAS SENT TO THE MANUFACTURER FOR FURTHER ANALYSIS. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE DEPUY CMW 1G 40G: THE SAMPLES WERE TESTED IN A TEMPERATURE AND HUMIDITY-CONTROLLED LABORATORY. TEST REVEALED THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE AND MET THE APPROPRIATE CONTROL SPECIFICATION. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4200143 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. WITH INFORMATION AVAILABLE, THE OVERALL COMPLAINT WAS NOT CONFIRMED FOR THE DEPUY CMW 1G 40G. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4200143 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4) INVESTIGATION SUMMARY ACCORDING TO THE INFORMATION PROVIDED: "IT WAS REPORTED THAT PATIENT WAS PRESENT IN THE OPERATING ROOM FOR AN INVERTED TOTAL SHOULDER REPLACEMENT. DURING THE CEMENTING OF THE HUMERAL STEM, THE CEMENT DOES NOT ADHERE TO THE STEM OR THE BONE. THE CEMENTED STEM WAS SMOOTH, AND THE HUMERAL SHAFT WAS WELL DRIED. THE CEMENT SHEATH HAD COME OFF IN ONE PIECE. (B)(4) RECORDED FOR THE FIRST PATIENT). A SECOND PATIENT PRESENTED THE SAME ISSUE WITH THE SAME CEMENT AND LOT, BUT THE STEMS WERE NOT THE SAME. (B)(4) RECORDED FOR THE SECOND PATIENT). EXTENSION OF THE PROCEDURE. ACTIONS WERE TAKEN FOR THE PATIENT REGARDING THE DEVICE: COMPLETELY REMOVED CEMENT, RE-CEMENTING OF THE STEM WITH A CEMENT FROM A DIFFERENT LOT. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES; HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT (PHOTOS OSIRIS CIMENT DEPUY). THE PHOTO INVESTIGATION REVEALED THE CEMENT MIX SHAPED AS THE STEM/IMPLANT. NO OTHER ANOMALY WAS NOTED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. A RETAIN SAMPLE TEST WAS PERFORMED FOR THE DEPUY CMW 1G 40G. THE SAMPLES WERE TESTED IN A TEMPERATURE AND HUMIDITY-CONTROLLED LABORATORY. TEST REVEALED THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE AND MET THE APPROPRIATE CONTROL SPECIFICATION. A FOLLOW UP WAS PERFORMED TO THE CUSTOMER TO PROVIDE FURTHER INVESTIGATION ON THE CEMENT/MIX DETAILS DURING SURGERY; HOWEVER, NO ANSWER WAS NOTIFIED. GIVEN THE CURRENTLY INFORMATION AND EVIDENCE PROVIDED, THE REPORTED ALLEGATION CAN BE CONFIRMED AS THE CUSTOMER MAY HAD EXPERIENCED CONSISTENCY ISSUES WITH THE CEMENT BUT CANNOT BE TRACED TO MANUFACTURING. THE MODE OF FAILURE OF THE DEVICE IS MULTI-FACTORIAL AND CONSIDERATION MUST BE GIVEN TO ALL OTHER POTENTIAL INFLUENCES SUCH AS CEMENT MIX AND SET TIME PROCESS, STORAGE AND OR TEMPERATURE, OR OTHER STEP DURING THE SURGICAL PROCESS. ANY CONCLUSIONS FROM THE INVESTIGATIONAL INPUT PROVIDED HAVE TO BE PLACED INTO CONTEXT WITH ALL OTHER RELEVANT FACTORS. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4200143 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE DEPUY CMW 1G 40G WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4200143 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. CORRECTION: D3, G1

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: D9 IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.