BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 53

    MDR report key: 3012065 · Received March 20, 2013

    Report

    Report Number
    1818910-2013-03925
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    August 5, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    **(B)(4). REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: PAIN; ELEVATED COBALT LEVELS; FLUID COLLECTION WHICH APPEARED TO BE THE RESULT OF METAL ON METAL WEAR; PSEUDOTUMOR; SLIGHT AMOUNT OF CORROSION; SOCKET APPEARED TO BE RETROVERTED AND SOMEWHAT VERTICAL AND WAS VERY WELL INGROWN. THE ADAPTER SLEEVE AND FEMORAL STEM HAVE BEEN ADDED TO THE COMPLAINT.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT. UPDATE: 03/12/2013 - SALES REP REPORTED REVISION SURGERY DUE TO PAIN. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115440 ASR UNI FEMORAL IMPL SIZE 53 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2747847

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention