BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML ACET CUP 50 OD 32 ID SP

    MDR report key: 2121603 · Received June 2, 2011

    Report

    Report Number
    1818910-2011-09657
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    P880025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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

    EXAMINATION OF THE RETURNED LINER CONFIRMS WEAR THROUGH OF THE LINER. IT IS NOTED THAT THE DEVICE WAS IMPLANTED FOR JUST OVER 17 YEARS. MATERIAL WEAR AFTER THIS LENGTH OF TIME WOULD NOT BE UNREASONABLE TO EXPECT. THE EVIDENCE / WEAR PATTERN INDICATES THE DEVICE WAS POSITIONED MORE VERTICALLY THAN RECOMMENDED BY SURGICAL TECHNIQUE CAUSING EDGE LOADING, WHICH ADVERSELY AFFECTED LOADING OF THE BEARING AND LIKELY INCREASED WEAR RATES. PER THE REPORTING, PATIENT X-RAYS ARE NOT AVAILABLE FOR EXAMINATION. THE INVESTIGATION HAS DETERMINED THAT THIS PRODUCT CODE HAS BEEN OBSOLETE SINCE FEBRUARY 2001. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PT WAS REVISED BECAUSE OF POLY WEAR COMPLETELY THROUGH THE LINER WHICH CREATED METALLOSIS BETWEEN THE HEAD AND THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AML ACET CUP 50 OD 32 ID SP TOTAL HIP PROSTHESIS LPH DEPUY ORTHOPAEDICS, INC. NA 749080

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention