BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP HEAD 32 MM

    MDR report key: 2881805 · Received December 20, 2012

    Report

    Report Number
    1818910-2012-84012
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    October 24, 2012
    Report Date
    December 3, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICES FINDS EVIDENCE TO SUPPORT DISASSOCIATION OF THE LINER AND CUP WHILE IMPLANTED. IN THIS CASE A PORTION OF THE RIM OF THE POLYETHYLENE LINER HAS FRACTURED. IT IS EVIDENT THAT THE EDGE OF THE LINER WAS LOADED BY THE FEMORAL HEAD AND PATIENT BODY WEIGHT WHILE IMPLANTED. THERE ARE MACHINING LINES YET VISIBLE WITHIN THE INNER RADIUS OF THE LINER WHICH WOULD NOT BE AS OBVIOUSLY PRESENT HAD THE FEMORAL HEAD BEEN MORE CENTRALLY LOADED. THE EDGE LOADING OF THE LINER HAS PLACED PRESSURES ON THE MATERIAL NEAR THE RIM THAT WERE NOT INTENDED LEADING TO A FRACTURE OF THE MATERIAL AND SUBSEQUENT DISASSOCIATION OF THE LINER FROM THE CUP. REVIEW OF PROVIDED PATIENT X-RAYS CONFIRMS THE FEMORAL HEAD APPEARS TO BE ECCENTRICALLY LOCATED WITHIN THE POLYETHYLENE INSERT OF THE ACETABULAR CUP SUGGESTING THE LINER HAS DISASSOCIATED FROM THE ACETABULAR SHELL. A REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT/LOT CODE COMBINATION. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    REVISION BECAUSE OF LOOSENING OF THE INLAY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIP HEAD 32 MM DEPUY HIP IMPLANT KWA DEPUY ORTHOPAEDICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention