BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM ACETABULAR COMPONENT

    MDR report key: 2845025 · Received November 8, 2012

    Report

    Report Number
    9613350-2012-01047
    Event Type
    Other
    Date Received
    November 8, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 12, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS FOR REVIEW, AS THE PATIENT HAS NOT BEEN REVISED TO DATE. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS CASE MIGHT BE RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN (B)(4) 2008 AS REFERENCED ABOVE H7 AND H9. 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 GMBH CONSIDERS THIS CAS AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE DUROM ACETABULAR CUP. IT WAS REPORTED THAT THE PATIENT RECEIVED AN IMPLANT ON (B)(6, 2007. ON (B)(6) 2012, SHE HAD SOME BLOOD TESTS AND AN MRI DONE WHICH SHOWED "FLUID". PATIENT "ALLEGES THAT DR. (B)(6) ADVISED THAT THE HIP MIGHT BE LOOSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2333040

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR