BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR ADAPTER SLEEVE

    MDR report key: 2252665 · Received September 18, 2011

    Report

    Report Number
    1818910-2011-18405
    Event Type
    Injury
    Date Received
    September 18, 2011
    Date of Event
    May 5, 2011
    Report Date
    August 29, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    PATIENT WAS REVISED TO ADDRESS PAIN AND OSTEOLYSIS. UPDATE: (B)(6) 2011 - MEDICAL RECORDS WERE RECEIVED. THE REVISION OPERATIVE REPORT INDICATES THAT THERE WAS A GALVANIC REACTION OF THE HEAD AGAINST THE FEMORAL STEM.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND OSTEOLYSIS. UPDATE: MEDICAL RECORDS WERE RECEIVED. THE REVISION OPERATIVE REPORT INDICATES THAT THERE WAS A GALVANIC REACTION OF THE HEAD AGAINST THE FEMORAL STEM. UPDATE: LITIGATION ALLEGED THE PATIENT SUFFERED SEVERE PAIN, DISABILITY, PHYSICAL IMPAIRMENT, DISFIGUREMENT, AGGRAVATION OF A PRE-EXISTING CONDITION, AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR ADAPTER SLEEVE HIP IMPLANT KWA DEPUY INTERNATIONAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention