BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIN TRIAL SHELL 51 STD PROFILE

    MDR report key: 20567916 · Received October 30, 2024

    Report

    Report Number
    1818910-2024-22670
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    October 15, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HWT
    UDI-DI
    10603295097624
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    DEPUY ORTHOPAEDICS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY ORTHOPAEDICS HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY ORTHOPAEDICS OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY ORTHOPAEDICS, 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: IT WAS REPORTED THAT CUP HANDLE COULD NOT BE REMOVED FROM CUP TRIAL. THREADS SEEM TO BE COLD WELDED TOGETHER. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND IT WAS RETURNED IN AN ASSEMBLED CONDITION. AFTER DISASSEMBLY, IT WAS OBSERVED THAT THE THREADS AT THE APEX HOLE WERE SEVERELY STRIPPED. POTENTIAL CAUSE CAN BE ATTRIBUTED TO UNINTENDED USE ERROR, THIS TYPE OF DAMAGE IS LIKELY DUE TO REPEATED SLIGHTLY OFF-AXIS ASSEMBLY, OVERTIGHTENING, PRYING MOTION WHILE ASSEMBLING AND HEAVY USAGE. PROPERLY HANDLING AND ATTENTION TO THE APPROVED USE OF THE DEVICE DIMINISHES THE RISK OF FAILURE. A DIMENSIONAL INSPECTION WAS NOT CONDUCTED DUE TO NOT BEING APPLICABLE TO THE COMPLAINT CONDITION. A FUNCTIONAL EVALUATION WAS REVEALED IT WAS EXTREMELY DIFFICULT TO DISASSEMBLE THE DEVICES. THE COMPLAINT CONDITION WAS REPLICATED HOWEVER THE ALLEGATION OF JAMMED SEIZED COULD NOT BE CONFIRMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE PIN TRIAL SHELL 51 STD PROFILE WOULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO UNINTENDED USE, AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS REQUIRED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS 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 PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CUP HANDLE COULD NOT BE REMOVED FROM CUP TRIAL. THREADS SEEM TO BE COLD WELDED TOGETHER. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042247 PIN TRIAL SHELL 51 STD PROFILE HIP INSTRUMENTS : ACETABULAR TRIALS HWT DEPUY IRELAND - 9616671 SO2033077 10603295097624

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown