SMARTSET GMV 40G US EO

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 WAS REVISED DUE TO LOOSENING OFF FEMORAL COMPONENT AT BONE TO CEMENT INTERFACE. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE." PRODUCT DESCRIPTION: SMARTSET GMV 40G US EO PRODUCT CODE: 545050501 LOT NUMBER: 4308680 QUANTITY OF MANUFACTURED: 2760 MANUFACTURING DATE: 25-OCT-2023 EXPIRY DATE: 30-SEP-2025. PRODUCT CHECKED: RETAINED SAMPLES. REQUIRED TESTING: TM-T150 CEMENT SETTING TIME THERE ARE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THE SAMPLES RETURNED WERE TESTED IN A TEMPERATURE AND HUMIDITY-CONTROLLED LABORATORY (SEE PAGES 2 AND 3). LOT: 4308680 DOUGH TIME: 02 MIN 57S (SPEC: 5 MIN 00S MAX) MIX CHARACTERISTICS: THIN SETTING TIME: 12 MIN 26S (SPEC: 9 MIN TO 13 MIN 30S). THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE AND MET THE APPROPRIATE CONTROL SPECIFICATION (REF: MS-039 MASTER SPECIFICATION: SMARTSET GMV 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 PRODUCT DESCRIPTION: SMARTSET GMV 40G US EO PRODUCT CODE: 545050501 LOT NUMBER: 4308680 QUANTITY OF MANUFACTURED: 2760 MANUFACTURING DATE: 25-OCT-2023 EXPIRY DATE: 30-SEP-2025. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. H11 ADDITIONAL NARRATIVE: CORRECTED: H3.

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# - 13704 TRADE NAME ¿ GENTAMICIN SULPHATE ACTIVE INGREDIENT(S) ¿ GENTAMICIN SULPHATE DOSAGE FORM - POWDER STRENGTH ¿ 1.0G ACTIVE IN OUR CEMENTS.

Description of Event or Problem

PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL COMPONENT AT BONE TO CEMENT INTERFACE. NO PATIENT CONSEQUENCES WERE NOTED. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.