BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 3183053 · Received June 21, 2013

    Report

    Report Number
    1818910-2013-19540
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    June 12, 2013
    Report Date
    August 9, 2013
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    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 THIS INVESTIGATION CLOSED.

    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

    PATIENT UNDERWENT REVISION PROCEDURE TO LEFT HIP DUE TO UNKNOWN REASON.

    Description of Event or Problem · 1

    UPDATE: (B)(6) 2013-LITIGATION PAPERS RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM PAIN AND EXCESSIVE LEVELS OF CHROMIUM COBALT.

    Description of Event or Problem · 1

    PATIENT UNDERWENT REVISION PROCEDURE TO LEFT HIP DUE TO UNKNOWN REASON. **UPDATE**(B)(4) 2013 - LITIGATION PAPERS RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM PAIN AND EXCESSIVE LEVELS OF CHROMIUM COBALT. **UPDATE** - MEDICAL RECORDS RECEIVED (B)(4) 2013. REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: SYNOVIAL HYPERTROPHY SLIGHTLY BROWNISH STAINED; RESORPTIVE CYST; FIBRINOUS DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282478 ASR UNI FEMORAL IMPL SIZE 45 FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 2322205

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention