BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEPUY ASR HIP

    MDR report key: 1884788 · Received October 22, 2010

    Report

    Report Number
    1818910-2010-07879
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    MM 38-10
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    **UPDATE** (B)(4) 2011 - DEVICE EXPERIENCE REPORT WAS RECEIVED DOCUMENTING PATIENTS REVISION SURGERY. THE PATIENT WAS REVISED TO ADDRESS ACETABULAR LOOSENING. DOI: (B)(6) 2008 - DOR: (B)(6) 2011 (LEFT SIDE) THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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

    LITIGATION PAPERS ALLEGE FOLLOWING THE SURGERY, PLAINTIFF, EXPERIENCED PAIN AND EXTREME WEAKNESS IN HIP AND QUADRICEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DEPUY ASR HIP ASR ACETABULAR CUPS KWA DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention