VMP + DEPUY CMW 3G 50G

Description of Event or Problem

IT WAS REPORTED THAT THE BLISTER THAT COMES WITH THE CEMENT IS BROKEN.

Additional Manufacturer Narrative

PRODUCT COMPLAINT #: (B)(4). 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: D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DMF# - (B)(4) TRADE NAME ¿ GENTAMICIN SULPHATE ACTIVE INGREDIENT(S) ¿ GENTAMICIN SULPHATE DOSAGE FORM - POWDER STRENGTH ¿ 1.0G ACTIVE IN OUR CEMENTS. 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 RECEIVED, "THE BLISTER THAT COMES WITH THE CEMENT IS BROKEN". THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE VIAL IS DAMAGED AND LIQUID SPILLAGE WITHIN THE PACKAGING. THE POTENTIAL CAUSE OF THE OBSERVED COMPLAINT CONDITION CANNOT BE TRACED TO A MANUFACTURING ISSUE. ONCE THE PRODUCT LEAVES DEPUY SYNTHES CONTROL, IT IS UNKNOWN WHAT ENVIRONMENT CONDITIONS OR HUMAN INTERVENTION OR MANIPULATION THE PACKAGED PRODUCTS ARE EXPOSED TO DURING THAT TIME. THEREFORE, THE SUSPECTED CAUSE IS TRACED TO TRANSPORT/STORAGE OUTSIDE OF DEPUY SYNTHES CONTROL. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3005050 / 4596159] NUMBER, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES RELATED TO THE COMPLAINT CONDITION WERE IDENTIFIED. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE VMP + DEPUY CMW 3G 50G WOULD HAVE CONTRIBUTED TO THE COMPLAINED 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 [3005050 / 4596159] NUMBER, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES RELATED TO THE COMPLAINT CONDITION WERE IDENTIFIED. DEVICE HISTORY REVIEW A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3005050 / 4596159] NUMBER, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES RELATED TO THE COMPLAINT CONDITION WERE IDENTIFIED. ADDED: D4 (EXPIRATION DATE), H4 CORRECTED: D4 (PRIMARY UDI)

Additional Manufacturer Narrative

PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY: THE BLISTER THAT COMES WITH THE CEMENT IS BROKEN PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT WHATSAPP IMAGE (B)(4). THE PHOTO INVESTIGATION REVEALED THAT THE AMBER VIAL APPEARS TO BE DAMAGED, WITH VISIBLE EVIDENCE OF LIQUID SPILLAGE INSIDE THE PACKAGING. THE REPORTED ALLEGATION CAN BE CONFIRMED. THE POTENTIAL CAUSE OF THE OBSERVED COMPLAINT CONDITION CANNOT BE TRACED TO A MANUFACTURING ISSUE. ONCE THE PRODUCT LEAVES DEPUY SYNTHES CONTROL, IT IS UNKNOWN WHAT ENVIRONMENT CONDITIONS OR HUMAN INTERVENTION OR MANIPULATION THE PACKAGED PRODUCTS ARE EXPOSED TO DURING THAT TIME. THEREFORE, THE SUSPECTED CAUSE IS TRACED TO TRANSPORT/STORAGE OUTSIDE OF DEPUY SYNTHES CONTROL. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE VMP + DEPUY CMW 3G 50G WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO TRANSPORT/STORAGE, AND 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 [3005050 / 4596159] NUMBER, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES RELATED TO THE COMPLAINT CONDITION WERE IDENTIFIED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, "THE BLISTER THAT COMES WITH THE CEMENT IS BROKEN". THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE VIAL IS DAMAGED AND LIQUID SPILLAGE WITHIN THE PACKAGING. THE POTENTIAL CAUSE OF THE OBSERVED COMPLAINT CONDITION CANNOT BE TRACED TO A MANUFACTURING ISSUE. ONCE THE PRODUCT LEAVES DEPUY SYNTHES CONTROL, IT IS UNKNOWN WHAT ENVIRONMENT CONDITIONS OR HUMAN INTERVENTION OR MANIPULATION THE PACKAGED PRODUCTS ARE EXPOSED TO DURING THAT TIME. THEREFORE THE SUSPECTED CAUSE IS TRACED TO TRANSPORT/STORAGE OUTSIDE OF DEPUY SYNTHES CONTROL. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3005050 / 4596159] NUMBER, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES RELATED TO THE COMPLAINT CONDITION WERE IDENTIFIED. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE VMP + DEPUY CMW 3G 50G WOULD HAVE CONTRIBUTED TO THE COMPLAINED 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 [3005050 / 4596159] NUMBER, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES RELATED TO THE COMPLAINT CONDITION WERE IDENTIFIED. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3005050 / 4596159] NUMBER, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES RELATED TO THE COMPLAINT CONDITION WERE IDENTIFIED. CORRECTED: H3.

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 THAT 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 RECON DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED:D9 IF INFORMATION THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT IS OBTAINED, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE BLISTER THAT COMES WITH THE CEMENT IS BROKEN. PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT WHATSAPP IMAGE 2025-11-26 AT 12.01.57.JPEG, WHATSAPP IMAGE 2025-11-26 AT 12.02.35.JPEG. THE PHOTO INVESTIGATION REVEALED THAT THE AMBER VIAL APPEARS TO BE DAMAGED, WITH VISIBLE EVIDENCE OF LIQUID SPILLAGE INSIDE THE PACKAGING. THE REPORTED ALLEGATION CAN BE CONFIRMED. THE POTENTIAL CAUSE OF THE OBSERVED COMPLAINT CONDITION CANNOT BE TRACED TO A MANUFACTURING ISSUE. ONCE THE PRODUCT LEAVES DEPUY SYNTHES CONTROL, IT IS UNKNOWN WHAT ENVIRONMENT CONDITIONS OR HUMAN INTERVENTION OR MANIPULATION THE PACKAGED PRODUCTS ARE EXPOSED TO DURING THAT TIME. THEREFORE THE SUSPECTED CAUSE IS TRACED TO TRANSPORT/STORAGE OUTSIDE OF DEPUY SYNTHES CONTROL. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE VMP + DEPUY CMW 3G 50G WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO TRANSPORT/STORAGE, AND 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 [3005050 / 4596159] NUMBER, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES RELATED TO THE COMPLAINT CONDITION WERE IDENTIFIED.