VMP + DEPUY CMW 3G 50G

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. ACCORDING TO THE INFORMATION RECEIVED,"THE HOSPITAL INDICATES THAT THE CEMENT IS DEFECTUOUS BECAUSE THE BLISTER COMES BROKEN (TWICE HAS HAPPENED TO THEM WITH THE SAME LOT) DID THE EVENT OCCUR DURING STERILE PROCESSING? UNKNOWN, DID THE EVENT OCCUR DURING FIELD INSPECTION? UNKNOWN, DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE". PRODUCT DESCRIPTION: - VMP + DEPUY CMW 3G 50G. PRODUCT CODE: - 3005050. LOT NO: - 4596159. QUANTITY OF MANUFACTURED: - (B)(4). DATE OF MANUFACTURING: - 19-SEP-2024. EXPIRY DATE: - 31-AUG-2026. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT DESCRIPTION: VMP + DEPUY CMW 3G 50G, PRODUCT CODE: 3005050, LOT NO: 4596159, AND FOUR NON-CONFORMANCES WAS IDENTIFIED, HOWEVER NOT RELATED TO THE REPORTED FAILURE MODE OF THE COMPLAINT. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 19-SEP-2024. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: YES, THERE WERE 4 NON-CONFORMANCES ON THIS LOT. ON REVIEW OF THE APPLICABLE NCS NONE HAVE BEEN IDENTIFIED WHICH WOULD CONTRIBUTE TO THE COMPLAINT EVENT. 4) EXPIRY DATE: 31-AUG-2026. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT DESCRIPTION: VMP + DEPUY CMW 3G 50G, PRODUCT CODE: 3005050, LOT NO: 4596159, AND FOUR NON-CONFORMANCES WAS IDENTIFIED, HOWEVER NOT RELATED TO THE REPORTED FAILURE MODE OF THE COMPLAINT.

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 HAT 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: D10 (CONCOMITANT). CORRECTED: D4 (PRIMARY UDI). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

THE HOSPITAL INDICATES THAT THE CEMENT IS DEFENCTUOSOS BECAUSE THE BLISTER COMES BROKEN (TWICE HAS HAPPENED TO THEM WITH THE SAME 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: DMF# - (B)(4). TRADE NAME ¿ GENTAMICIN SULPHATE. ACTIVE INGREDIENT(S) ¿ GENTAMICIN SULPHATE. DOSAGE FORM - POWDER. STRENGTH ¿ 1.0G ACTIVE IN OUR CEMENTS.