BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 53

    MDR report key: 3083458 · Received April 29, 2013

    Report

    Report Number
    1818910-2013-02895
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    August 4, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. (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.

    Description of Event or Problem · 1

    PATIENT CONTACTED BROADSPIRE TO INITIATE CLAIM. PATIENT REPORTED REVISION SURGERY. REASON FOR REVISION IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.THIS IS A CLINICAL PATIENT, REPORT INDICATES THAT THE PATIENT HAD PAIN/STIFFNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184494 ASR UNI FEMORAL IMPL SIZE 53 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2077255

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other