BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER MMC CUP 56 MM/48 MM CODE N

    MDR report key: 3012310 · Received March 12, 2013

    Report

    Report Number
    9613350-2013-01420
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    January 9, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. A PRODUCT FAILURE CANNOT BE CONFIRMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT RECEIVED A ZIMMER MMC CUP 56 MM/48 MM CODE N ON THE LEFT SIDE ON (B)(6) 2010 AND UNDERWENT REVISION SURGERY ON (B)(6) 2013, DUE TO "ADVERSE REACTIONS TO METALLIC DEBRIS, POSTERIOR PSEUDO TUMOR AND IMPINGEMENT BETWEEN NECK AND CUP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104485 ZIMMER MMC CUP 56 MM/48 MM CODE N ZIMMER MMC CUP KWA ZIMMER GMBH 2522497

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R