CONTROL CABLE W/CABLE SLEEVE

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: D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. E1: REPORTER IS A LEGAL PROFESSIONAL. H3, H6: A SEARCH OF THE MEDTECH ORTHOPAEDICS (NC) QUALITY SYSTEM FOUND NO NONCONFORMANCES ASSOCIATED WITH THIS PRODUCT/LOT (PRODUCT CODE: 173928000, LOT - B4SB71000) COMBINATION. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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.

Description of Event or Problem

PATIENT WAS REVISED DUE TO FAILED RIGHT TOTAL HIP ARTHROPLASTY FROM RECALLED ACETABULAR IMPLANT. PATIENT WAS EXPERIENCING WORSENING PAIN AND CALCAR WAS IMPACTED THERE WAS NOTED TO BE A CRACK. SIGNIFICANT METALLIC STAINING OF THE SYNOVIAL LAYER. EVIDENCE OF TRUNNION CORROSION. DOI: (B)(6) 2007, DOR: (B)(6) 2023, AFFECTED SITE: RIGHT HIP,