BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 43

    MDR report key: 2802989 · Received October 24, 2012

    Report

    Report Number
    1818910-2012-23858
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    December 30, 2013
    Report Date
    December 30, 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
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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. (B)(4).

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013- SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS PAIN. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE, THE PATIENT SUFFERS FROM PAIN, ELEVATED METAL ION LEVELS, DISFIGUREMENT, PHYSICAL IMPAIRMENT AND EMOTIONAL STRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 43 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL 2170045

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other