BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 53

    MDR report key: 4212165 · Received October 29, 2014

    Report

    Report Number
    1818910-2014-30903
    Event Type
    Injury
    Date Received
    October 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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. WWCAPA (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. (B)(4).

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER WPC (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ LITIGATION PAPERS ALLEGE THAT PATIENT EXPERIENCED PAIN AND SUFFERING; DISABILITY; IMPAIRMENT; LOSS OF FUNCTION, USE AND RANGE OF MOTION; DECREASED AND POOR HIP PERFORMANCE; GAIT DISTURBANCE; METALLIC AND OTHER PARTICULATE CONTAMINATION OF THE BLOOD AND BODY; EXACERBATION OF UNDERLYING HIP JOINT DISORDERS; INTERNAL SCARRING; AND IRRITATION AND INJURY TO THE TENDONS, LIGAMENTS, MUSCLES, BLOOD VESSELS, CARTILAGES, NERVES, BONES AND SOFT TISSUES OF THE HIP JOINT AND SURROUNDING AREAS. PATIENT HAS NOT YET SCHEDULED AN EXPLANTATION OF THE ASR HIP IMPLANT. UPDATE REC¿D 09/29/2014- PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION FROM PATIENT STICKER SHEET. FEMORAL HEAD IS BEING REPORTED. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 10/29/2014

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691599 ASR UNI FEMORAL IMPL SIZE 53 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD - 8010379 1979054

    Patients

    Seq Age Sex Outcome Treatment
    1 Other