BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 55

    MDR report key: 2840952 · Received November 20, 2012

    Report

    Report Number
    1818910-2012-24210
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 4, 2012
    Report Date
    November 10, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT THE ASR IMPLANT WAS FAILING AND THE PATIENT HAD HIGH CONCENTRATIONS OF VARIOUS METALLIC ELEMENTS IN HIS BLOOD AS A RESULT. THE PATIENT SUFFERED INJURIES OF A PERMANENT NATURE; ENDURED PAIN AND SUFFERING AND IS UNABLE TO ATTEND TO HIS NORMAL AFFAIRS AND DUTIES FOR AN INDEFINITE PERIOD OF TIME.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE PATIENT WAS REVISED DUE TO FLUID COLLECTION AND PSEUDOTUMOR. DURING REVISION, THICKENED AND PATHOLOGIC BURSAL TISSUE CONSISTENT WITH PSEUDOTUMOR, EVIDENCE OF CORROSION AT THE HEAD TRUNNION JUNCTURE AND NECROTIC TISSUE WERE FOUND. THE FEMORAL STEM AND FEMORAL SLEEVE HAVE BEEN ADDED TO THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 55 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2176459

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention