BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR +4 10D 36IDX52OD

    MDR report key: 3120633 · Received May 20, 2013

    Report

    Report Number
    1818910-2013-17400
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK033273
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    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. THE RETURNED FEMORAL HEAD EXHIBITS SIGNS OF COMING INTO DIRECT CONTACT WITH THE ACETABULAR CUP, FURTHER SUPPORTING THE DISASSOCIATION. IT IS SUSPECTED THAT THE ACETABULAR CUP WAS POSITIONED MORE VERTICALLY THAN RECOMMENDED BY SURGICAL TECHNIQUE CONTRIBUTING TO THE EDGE LOADING. A REVIEW OF DEVICE HISTORY RECORDS FOUND ALL PRODUCTS WERE MANUFACTURED PER SPECIFICATION AND NO MANUFACTURING DEVIATIONS OR ANOMALIES WERE FOUND. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT/LOT CODE COMBINATION. THE INVESTIGATION HAS FOUND NO PRODUCT PROBLEM IDENTIFIED THEREIN. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    REVISION WAS PERFORMED AND IT WAS DISCOVERED THAT THE EDGE OF THE LINER HAD BEEN BROKEN AND METAL HEAD WAS RUBBING AGAINST METAL CUP. PATIENT HAD METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221464 PINN MAR +4 10D 36IDX52OD ACETABULAR LINER LPH DEPUY ORTHOPAEDICS FE6WS1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention