BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2232308 · Received August 18, 2011

    Report

    Report Number
    1818910-2011-15761
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - LITIGATION PAPERS ALLEGE AS A RESULT OF ONE OR MORE OF THE ASR IMPLANTS, THE PATIENT WAS CAUSED TO SUFFER AND SUSTAIN INJURIES OF A PERMANENT NATURE; TO ENDURE PAIN AND SUFFERING AND IS UNABLE TO ATTEND TO HIS NORMAL AFFAIRS AND DUTIES FOR AN INDEFINITE PERIOD OF TIME. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY STILL 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

    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 CAUSES(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.

    Description of Event or Problem · 1

    BILATERAL PATIENT WAS REVISED TO ADDRESS PAIN. SKIN RASH AROUND BOTH INCISION AREAS WAS REPORTED. BOTH JOINTS SHOWED EVIDENCE OF METALOSIS AND TISSUE RESPONSE. THE ACETABULAR CUPS WERE LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2963237

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention