BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 2951103 · Received February 8, 2013

    Report

    Report Number
    1818910-2013-02085
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    August 24, 2018
    Report Date
    January 10, 2012
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4) USED TO CAPTURE THE SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERED ELEVATED COBALT LEVELS AS WELL AS OTHER KNOWN OR UNKNOWN MEDICAL COMPLICATIONS.

    Description of Event or Problem · 1

    LITIGATION RECORD RECEIVED. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, LITIGATION ALLEGES THAT THE PATIENT UNDERWENT A RIGHT HIP REVISION SURGERY ON (B)(6) 2018. DOI: (B)(6) 2006; DOR: (B)(6) 2018; RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54997 ASR UNI FEMORAL IMPL SIZE 49 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL LTD - 8010379 2249282

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R ADAPTER SLEEVES 12/14 +5.| ASR ACETABULAR CUPS 56.| SUMMIT POR TAPER SZ4 HI OFF.