BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2071628 · Received April 15, 2011

    Report

    Report Number
    1818910-2011-06641
    Event Type
    Injury
    Date Received
    April 15, 2011
    Report Date
    May 10, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT AS A RESULT OF EXCRUCIATING PAIN, MULTIPLE DISLOCATIONS OF THE NEWLY IMPLANTED HIP SYSTEM AND THE INABILITY TO WALK, PATIENT UNDERWENT REVISION SURGERY. IT IS FURTHER ALLEGED PATIENT HAS AND WILL CONTINUE TO SUFFER EXCRUCIATING PAIN AND PATIENT REQUIRES ONGOING TREATMENT AND REHABILITATION. UPDATE LITIGATION ALLEGED THE ASR HIP WAS EXPLANTED DUE TO DEVICE FAILURE, PAIN AND OTHER INJURIES DUE TO EXCESSIVE LEVELS OF CHROMIUM AND COBALT.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT AS A RESULT OF EXCRUCIATING PAIN, MULTIPLE DISLOCATIONS OF THE NEWLY IMPLANTED HIP SYSTEM AND THE INABILITY TO WALK, PATIENT UNDERWENT REVISION SURGERY. IT IS FURTHER ALLEGED PATIENT HAS AND WILL CONTINUE TO SUFFER EXCRUCIATING PAIN AND PATIENT REQUIRES ONGOING TREATMENT AND REHABILITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL, LTD. NA 2542077

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention