BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 2142948 · Received June 23, 2011

    Report

    Report Number
    1818910-2011-10878
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 7, 2013
    Report Date
    August 14, 2013
    Manufacturer
    DEPUY INTERNATIONAL, LTD
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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

    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.

    Additional Manufacturer Narrative · 1

    THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE REPORT OF 1818910-2013-06826. THIS REPORT, 1818910-2011-10878 WILL BE KEPT FOR INVESTIGATION PURPOSES. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HIS LEFT SIDE ON OR ABOUT (B)(6) 2009. PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HIS RIGHT SIDE ON OR ABOUT (B)(6) 2010. AFTER HIS SURGERIES, PATIENT EXPERIENCED PAIN AND DISCOMFORT IN BOTH HIPS, ALONG WITH METALLOSIS EXPOSURE, EXCESSIVE LEVELS OF COBALT AND CHROMIUM IN HIS BLOOD, AND OTHER INJURIES PRESENTLY UNDIAGNOSED. PATIENT HAS NOT SCHEDULED REVISION SURGERIES FOR EITHER SIDE.

    Description of Event or Problem · 1

    **UPDATE** - MEDICAL RECORDS WERE RECEIVED (B)(4) 2013. REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: PAIN, PSEUDOTUMOR; VERY THICKENED HIP CAPSULE WITH EFFUSION; TISSUE APPEARED AS CLASSIC METALLIC DEBRIS. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 47 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL, LTD NA 2887964

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention