BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER MMC CUP 64MM/56MM CODE V

    MDR report key: 2032572 · Received March 15, 2011

    Report

    Report Number
    9613350-2011-00154
    Event Type
    Injury
    Date Received
    March 15, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER (B)(4) WHICH MARKETS THE DEVICES IN THE (B)(6). THE MANUFACTURER DID NOT RECEIVE EXPLANTED DEVICES OR X-RAYS. THE SURGICAL REPORTS AND CRF PROVIDED DID NOT REVEAL A POSSIBLE ROOT CAUSE FOR THE ALLEGED EVENT. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. IT IS NOT SUSPECTED THAT PRODUCT FAILURE LEAD TO THE ALLEGED EVENT. SHOULD ADDITIONAL INFO 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 FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE CLOSED. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT UNDERWENT REVISION 6 WEEKS AFTER INITIAL SURGERY (THA WITH MMC CUP) DUE TO A DEEP INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER MMC CUP 64MM/56MM CODE V ZIMMER MMC CUP KWA ZIMMER GMBH 2528738

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR