DEPUY/CMW 2G

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WITH RA WAS REVISED DUE TO LOOSENING COMPONENTS AT CEMENT TO BONE INTERFACE. NO ADVERSE CONSEQUENCES REPORTED. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

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: "DMF# - 13704. 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: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. ACCORDING TO THE INFORMATION RECEIVED,¿ PATIENT WITH RA REVISED DUE TO LOOSENING COMPONENTS AT UNKNOWN INTERFACE. NO ADVERSE CONSEQUENCES REPORTED. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE". LOT: 3952620. MANUFACTURING DATE: 30 SEP 22. EXPIRY DATE: 31 AUG 25. QUANTITY: (B)(4). PRODUCT CHECKED: RETAINED SAMPLES. REQUIRED TESTING: TM-T150 CEMENT SETTING TIME THERE WAS ONE NON-CONFORMANCES ASSOCIATED WITH THIS LOT. ON REVIEW OF THE APPLICABLE NC, IT HAS BEEN IDENTIFIED THAT THE NC WOULD NOT HAVE CONTRIBUTED TO THE COMPLAINT EVENT THE SAMPLES WERE TESTED IN A TEMPERATURE AND HUMIDITY-CONTROLLED LABORATORY. LOT: 3952620. DOUGH TIME: 37S (SPEC: 1 MIN 30S MAX). MIX CHARACTERISTICS: STIFF. SETTING TIME: 4 MIN 47S (SPEC: 4 MIN TO 6 MIN). THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE AND MET THE APPROPRIATE CONTROL SPECIFICATION (REF: MS-005 MASTER SPECIFICATION: DEPUY CMW 2G GENTAMICIN BONE CEMENT). 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: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED.