DEPUY CMW 1G 40G

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY- DURING THE CEMENTING OF THE HUMERAL STEM, THE CEMENT DOES NOT ADHERE TO THE STEM OR THE BONE. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT (PHOTOS OSIRIS CIMENT DEPUY). THE PHOTO INVESTIGATION REVEALED THAT THE EVIDENCE PROVIDED WAS FROM THE FIRST REPORTED EVENT, THEREFORE, THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS DUE TO THE INSUFFICIENT EVIDENCE PROVIDED. 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. 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 NOT CONFIRMED AS THE PHOTOGRAPHS PROVIDED ARE NOT REPRESENTATIVE OF THE REPORTED EVENT. 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 PRODUCT DESCRIPTION: DEPUY CMW 1G 40G PRODUCT CODE: 3315040 LOT NUMBER: 4200143 AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED THAT WOULD CONTRIBUTE TO THE REPORTED ISSUE. DEVICE HISTORY REVIEW- A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT DESCRIPTION: DEPUY CMW 1G 40G PRODUCT CODE: 3315040 LOT NUMBER: 4200143 AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED THAT WOULD CONTRIBUTE TO THE REPORTED ISSUE.

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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

Description of Event or Problem

PATIENT PRESENT IN THE OPERATING ROOM FOR AN INVERTED TOTAL SHOULDER REPLACEMENT. DURING THE CEMENTING OF THE HUMERAL STEM, THE CEMENT DID NOT ADHERE TO THE STEM OR THE BONE. THE CEMENTED STEM IS SMOOTH, AND THE HUMERAL SHAFT IS WELL DRIED. THE CEMENT SHEATH HAS COME OFF IN ONE PIECE. COMPLETELY REMOVED CEMENT, RE-CEMENTING OF THE STEM WITH A CEMENT FROM A DIFFERENT LOT. EXTENSION OF THE PROCEDURE.

Additional Manufacturer Narrative

PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: DURING THE CEMENTING OF THE HUMERAL STEM, THE CEMENT DOES NOT ADHERE TO THE STEM OR THE BONE. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES; HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT THE EVIDENCE PROVIDED WAS FROM THE FIRST REPORTED EVENT; THEREFORE, THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS DUE TO THE INSUFFICIENT EVIDENCE PROVIDED. 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 CURRENT 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-CONFORMANCE'S NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE PHOTOGRAPHS PROVIDED ARE NOT REPRESENTATIVE OF THE REPORTED EVENT. 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 PRODUCT DESCRIPTION: DEPUY CMW 1G 40G, PRODUCT CODE: 3315040, LOT NUMBER: 4200143 AND NO NON-CONFORMANCE'S OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED THAT WOULD CONTRIBUTE TO THE REPORTED ISSUE. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT DESCRIPTION: DEPUY CMW 1G 40G, PRODUCT CODE: 3315040, LOT NUMBER: 4200143 AND NO NON-CONFORMANCE'S OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED THAT WOULD CONTRIBUTE TO THE REPORTED ISSUE. ADDED: G4 PMA/ 510(K). CORRECTED: D2B, D3.