BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2142702 · Received June 23, 2011

    Report

    Report Number
    1818910-2011-11079
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    November 28, 2010
    Report Date
    May 24, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    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

    **UPDATE** * 01/10/2012 PATIENT FACT SHEET FORM WAS RECEIVED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS HIP PAIN ATTRIBUTED TO ACETABULAR CUP LOOSENING. UPDATE ON (B)(6) 2011 - MEDICAL RECORDS WERE RECEIVED. THE REVISION OPERATIVE REPORT INDICATES THE PATIENT HAD ELEVATED METAL ION LEVELS AND AREAS OF BLACK TISSUE CONSISTENT WITH METAL WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2394234

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention