BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUP 52

    MDR report key: 3132270 · Received May 29, 2013

    Report

    Report Number
    1818910-2013-05986
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    August 26, 2015
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. REF. (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 THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    **UPDATE** (B)(4) 2013 - PPD RECEIVED. PART/LOT INFO UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY CONSIDERS THIS COMPLAINT CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD SEVERE AND PERSISTENT PAIN WHICH INCREASED, DIFFICULTY WALKING, DECREASED RANGE OF MOTION, DIFFICULTY PERFORMING ACTIVITIES OF DAILY LIVING, LOSS OF MUSCLE MASS AND DETERIORATION OF SOFT TISSUES IN HIP DUE TO HIGH METAL LEVELS IN BLOODSTREAM AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    UPDATE REC'D (B)(4) 2015 - LITIGATION PAPERS ALLEGE EXCESSIVE LEVELS OF CHROMIUM AND COBALT, PAIN, DISCOMFORT, SWELLING, LOSS OF ENERGY, MALAISE, SORENESS, AND LOCALIZED DAMAGE TO TISSUE AND/OR BONE SURROUNDING THE ACETABULUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237450 ASR ACETABULAR CUP 52 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2164123

    Patients

    Seq Age Sex Outcome Treatment
    1 Other