BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT

    MDR report key: 1870107 · Received October 11, 2010

    Report

    Report Number
    9613350-2010-00472
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 1, 2008
    Report Date
    September 13, 2010
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICE IN THE U.S. THE MANUFACTURER DID NOT RECEIVED EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR EXPLANTED DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE CLOSED. (B)(4)

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT HAD ZIMMER DUROM CUPS REPLACED IN BOTH HIPS. RIGHT HIP IN (B)(6) 2007 AND THE LEFT IN (B)(6) 2008. PATIENT HAD CHRONIC PROBLEMS WITH THE LEFT HIP SINCE (B)(6) 2008. SHE HAS A SLIPPAGE, GROIN PAIN AND PINCHING AND LACK OF STRENGTH AND BALANCE ON THE LEFT LEG. REVISION SURGERY NOT SCHEDULED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R