BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR SZ. 57 HEAD

    MDR report key: 2071636 · Received April 15, 2011

    Report

    Report Number
    1818910-2011-06267
    Event Type
    Injury
    Date Received
    April 15, 2011
    Report Date
    March 18, 2011
    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
    AL, 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

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

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT AFTER IMPLANTATION, PATIENT BEGAN TO SUFFER FROM SEVERE PAIN AND SYMPTOMS OF A FAILED IMPLANT. IT IS FURTHER ALLEGED THAT PATIENTS PHYSICIANS HAVE EXAMINED AND ADVISED HIM THAT HE WILL BE REQUIRED TO UNDERGO REVISION SURGERY. IT IS ADDITIONALLY ALLEGED THAT PATIENT SUSTAINED AND CONTINUES TO SUFFER DAMAGES, INCLUDING, BUT NOT LIMITED TO, PAST, PRESENT, AND FUTURE PAIN AND SUFFERING, SEVERE AND POSSIBLY PERMANENT INJURIES, EMOTIONAL DISTRESS, DISABILITY, DISFIGUREMENT, ECONOMIC DAMAGES (INCLUDING MEDICAL AND HOSPITAL EXPENSES) MONITORING, REHABILITATIVE AND PHARMACEUTICAL COSTS, AND LOST WAGES AND LOSS OF FUTURE EARNINGS CAPACITY. (B)(6), 2011 - THE SALES REP HAS REPORTED THE REVISION SURGERY. REASON FOR REVISION IS UNKNOWN.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT AFTER IMPLANTATION, PATIENT BEGAN TO SUFFER FROM SEVERE PAIN AND SYMPTOMS OF A FAILED IMPLANT. IT IS FURTHER ALLEGED THAT PATIENT'S PHYSICIANS HAVE EXAMINED AND ADVISED HIM THAT HE WILL BE REQUIRED TO UNDERGO REVISION SURGERY. IT IS ADDITIONALLY ALLEGED THAT PATIENT SUSTAINED AND CONTINUES TO SUFFER DAMAGES, INCLUDING BUT NOT LIMITED TO, PAST, PRESENT, AND FUTURE PAIN AND SUFFERING, SEVERE AND POSSIBLY PERMANENT INJURIES, EMOTIONAL DISTRESS, DISABILITY, DISFIGUREMENT, ECONOMIC DAMAGES (INCLUDING MEDICAL AND HOSPITAL EXPENSES) MONITORING, REHABILITATIVE AND PHARMACEUTICAL COSTS, AND LOST WAGES AND LOSS OF FUTURE EARNING CAPACITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR SZ. 57 HEAD NONE KWA DEPUY INTERNATIONAL, LTD. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention