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, ¿(B)(4) MEDICAL RECORD AD 19 JUN 2025 WAS REVIEWED BY CLINICIAN. ON (B)(6) 2016, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS DEGENERATIVE JOINT DISEASE. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2025, THE PATIENT HAD A LEFT TOTAL REVISION TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT WITH DEBONDING OF THE CEMENT, MEDICAL POLYETHYLENE WEAR WITH SOME OSTEOLYSIS, MILD MID FLEXION INSTABILITY WITH EXTERNAL ROTATION OF THE FEMORAL COMPONENT. THE INDICATIONS FOR SURGERY INCLUDE PAIN. (DOI: (B)(6) 2016 DOR: (B)(6) 2025 LEFT KNEE)". DATE OF RELEASE: 2015-04 EXPIRY DATE: 2016-12 QUANTITY:(B)(4). THERE WERE ZERO NONCONFORMANCES ON THIS LOT. ALL QC AND MICROBIOLOGY TESTING MET SPECIFICATION. A REVIEW OF THE DHR HAS CONFIRMED THAT THERE WERE NO PROCESS ISSUES DOCUMENTED THAT COULD CONTRIBUTE TO THE EVENT DESCRIBED. 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 ==> DATE OF RELEASE: 2015-04 EXPIRY DATE: 2016-12 QUANTITY: (B)(4). THERE WERE ZERO NONCONFORMANCES ON THIS LOT. ALL QC AND MICROBIOLOGY TESTING MET SPECIFICATION. A REVIEW OF THE DHR HAS CONFIRMED THAT THERE WERE NO PROCESS ISSUES DOCUMENTED THAT COULD CONTRIBUTE TO THE EVENT DESCRIBED. DEVICE HISTORY REVIEW ==> A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. CORRECTED INFORMATION: D4 (PRIMARY UDI #, EXPIRATION DATE), H4 .

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. E1: REPORTER IS A LEGAL PROFESSIONAL.

Description of Event or Problem

ON (B)(6) 2016, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS DEGENERATIVE JOINT DISEASE. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2025, THE PATIENT HAD A LEFT TOTAL REVISION TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT WITH DEBONDING OF THE CEMENT, MEDICAL POLYETHYLENE WEAR WITH SOME OSTEOLYSIS, MILD MID FLEXION INSTABILITY WITH EXTERNAL ROTATION OF THE FEMORAL COMPONENT. THE INDICATIONS FOR SURGERY INCLUDE PAIN. DOI: (B)(6) 2016, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.