BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER MMC CUP

    MDR report key: 2800976 · Received October 18, 2012

    Report

    Report Number
    9613350-2012-00986
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 17, 2010
    Report Date
    October 4, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE 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 CASE 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. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT RECEIVED AN MMC CUP AND DUROM FEMORAL COMPONENT, ON (B)(6) 2010 AND UNDERWENT REVISION SURGERY DUE TO INCREASED METAL IONS CONCENTRATIONS. THE REVISION SURGERY WAS COMPLETED ON (B)(6) 2012. PATIENT HAD NO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER MMC CUP ZIMMER MMC CUP 60 MM / 52 MM KWA ZIMMER GMBH 2514091

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R