BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL 45

    MDR report key: 2832010 · Received November 14, 2012

    Report

    Report Number
    1818910-2012-26805
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 30, 2012
    Report Date
    July 12, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LITIGATION ALLEGES PATIENT HAD PAIN AND TWO DISLOCATIONS AFTER ASR HIP IMPLANT. DEPUY STILL 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

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    **UPDATE** (B)(4) 2013 - PPD RECEIVED. PART/LOT AND DOI HAVE BEEN 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

    PATIENT WAS REVISED DUE TO DISLOCATION. (RIGHT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL 45 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2546382

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention