BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 53

    MDR report key: 2920527 · Received January 17, 2013

    Report

    Report Number
    1818910-2013-00653
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    October 22, 2012
    Report Date
    July 8, 2011
    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
    NY, 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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL 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

    LITIGATION PAPERS ALLEGE THE PATIENT HAS SUFFERED AND CONTINUES TO SUFFER BOTH INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO: PAST, PRESENT AND FUTURE PHYSICAL AND MENTAL PAIN AND SUFFERING; AND PAST, PRESENT AND FUTURE MEDICAL, HOSPITAL, REHABILITATIVE AND PHARMACEUTICAL EXPENSES, LOST WAGES, AND OTHER RELATED DAMAGES. ON (B)(6) 2012 - PATIENT'S OPERATIVE RECORDS RECEIVED. RECORDS INDICATE THE PATIENT'S CUP AND HEAD WERE REVISED DUE TO PAIN. UPON REVISION, EXTENSIVE METALLOSIS WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25583 ASR UNI FEMORAL IMPL SIZE 53 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2647771

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention