BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2202327 · Received August 8, 2011

    Report

    Report Number
    1818910-2011-14545
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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 INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LEGAL CLAIM ALLEGES: PT WAS IMPLANTED WITH A DEPUY ASR HIP ON (B)(6) 2009. PT IS SCHEDULED TO UNDERGO REVISION SURGERY ON (B)(6) 2011. PT REPORTED THAT WHEN HE WAS STANDING, HE COULD FEEL THE PROSTHESIS MOVING/SHIFTING. HE ALSO FELT THAT THE BALL MOVING IN THE SOCKET HAD DEVELOPED SOME PLAY. ADDITIONALLY, HE BEGAN TO EXPERIENCE PAIN IN HIS HIP IN THE AREA OF THE IMPLANT. A TEST REVEALED THAT HIS CHROMIUM AND COBALT LEVELS WERE HIGH. UPDATE (B)(6) 2011 - THE SALES REP REPORTED THE REVISION SURGERY. THE PT WAS REVISED TO ADDRESS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 87KWA KWA DEPUY INTL., LTD. NA 2776292

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention