BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 58

    MDR report key: 2230037 · Received August 31, 2011

    Report

    Report Number
    1818910-2011-16979
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    July 12, 2010
    Report Date
    November 19, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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. OTHER TEXT: DEVICE NOT RETURNED TO MFG.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT WAS REVISED TO ADDRESS DISCOMFORT, PAIN, AND SORENESS, WHICH IN TURN NEGATIVELY AFFECTED THE PATIENTS ABILITY TO WALK, MOVE, AND RISE FROM A CHAIR. HE WAS FOUND TO HAVE ELEVATED COBALT LEVELS. IT WAS FURTHER ALLEGED THAT DURING THE REVISION SURGERY, THE SURGEON DISCOVERED GROSS EVIDENCE OF METALLOSIS AND THE ACETABULAR COMPONENT WAS DISCOVERED TO BE NOT INGROWN.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - MEDICAL RECORDS WERE OBTAINED. AS GROSS METALLOSIS WAS FOUND UPON REVISION, METAL SHEDDING DEBRIS WILL BE REPORTED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 58 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL 2776283

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention