CONTROL CABLE W/CABLE SLEEVE

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4) INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A SEARCH OF THE MEDTECH ORTHOPEDICS NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT<173928000>/LOT<M8673F> COMBINATION. 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 SEARCH OF THE MEDTECH ORTHOPEDICS NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT<173928000>/LOT<M8673F> COMBINATION. H11 ADDITIONAL NARRATIVE: ADDED: D10.

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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT DESPITE REPEATED ATTEMPTS TO CURE THE SYSTEMIC INFECTION THIS PATIENT HAD, PATIENT CONTINUED TO SHOW INFECTION AND IT WAS DECIDED TO REMOVE THE IMPLANTS IN HIS RIGHT LEG AND PERFORM AN ABOVE KNEE AMPUTATION. ALL COMPONENTS PERFORMED AS EXPECTED TO THERE WAS NO ALLEGATION AGAINST THE COMPONENTS. THIS SUBMISSION IS BEING MADE AS THE IMPLANTS WERE REMOVED. DOI: (B)(6) 2025, 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. THIS REPORT MAY BE BASED ON INFORMATION THAT 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 THAT 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: B5, D4 LOT, H6 HEALTH EFFECT CLINICAL CODE. IF INFORMATION THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT IS OBTAINED, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: CAN YOU PROVIDE ANY INFORMATION REGARDING WHEN THE INFECTION BEGAN AND IF THERE WERE ANY PREVIOUS DEPUY PRODUCTS THAT HAVE BEEN REVISED AND/OR REPORTED. LATE ON (B)(6) 2025. PATIENT HAD BILATERAL DEPUY KNEE REPLACEMENTS IN WHEN HE WAS ADMITTED WITH SEPSIS. HE HAD BOTH SHOULDER, NATIVE, AND BOTH KNEES INFECTED AT THAT TIME.