SMARTSET GMV 40G US EO

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: IT WAS REPORTED THAT PATIENT'S KNEE WAS REVISED DUE TO ASEPTIC LOOSENING OF HIS PRIMARY FEMORAL AND TIBIAL COMPONENTS. DURING THE REVISION PROCEDURE, THE PATIENT'S PRIMARY ATTUNE COMPONENTS WERE REMOVED AND REPLACED BY ATTUNE REVISION COMPONENTS. THE LOOSENING OCCURRED PRIMARILY BETWEEN THE BONE AND CEMENT INTERFACE. THE CEMENT USED WOULD HAVE BEEN SMARTSET GMV BONE CEMENT, SINCE IT IS THE ONLY CEMENT USED AT THIS HOSPITAL FOR CEMENTED TOTAL KNEE ARTHROPLASTIES. THE LOT NUMBERS FOR THE CEMENT WAS UNKNOWN, SINCE THE HOSPITAL PURCHASED ITS CEMENT DIRECTLY FROM DEPUY SYNTHES. LOOSENING INTERFACE WAS MARKED AS BONE TO CEMENT. CEMENT RESIDUES ATTACHED TO THE IMPLANTS RETURNED WERE OBSERVED WHICH INDICATES A GOOD FIXATION BETWEEN THE INTERFACE, HOWEVER WITH THE EVIDENCE PROVIDED, IT IS NOT POSSIBLE TO CONFIRM THE REPORTED LOOSENING BETWEEN THE BONE AND CEMENT. THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE HISTORY REVIEW AND RETAINED SAMPLE TEST COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE SMARTSET GMV 40G US EO WOULD HAVE NOT CONTRIBUTED TO THE COMPLAINED DEVICE 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: THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE HISTORY REVIEW AND RETAINED SAMPLE TEST COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.

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. 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

IT WAS REPORTED THAT PATIENT'S KNEE WAS REVISED DUE TO ASEPTIC LOOSENING OF HIS PRIMARY FEMORAL AND TIBIAL COMPONENTS. DURING THE REVISION PROCEDURE, THE PATIENT'S PRIMARY ATTUNE COMPONENTS WERE REMOVED AND REPLACED BY ATTUNE REVISION COMPONENTS. THE LOOSENING OCCURRED PRIMARILY BETWEEN THE BONE AND CEMENT INTERFACE. DOI: (B)(6) 2022. 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: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. "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.