BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL HEAD 32, 12/14, SIZE XXL/+10.5

    MDR report key: 1997679 · Received February 11, 2011

    Report

    Report Number
    9613350-2011-00067
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 21, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICES IN THE U.S. THE MANUFACTURER DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. 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 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 AFTER PHYSICAL THERAPY, PATIENT WAS EXPERIENCING PAIN AND X-RAY SHOWED LESSER TROCHANTER SPLIT OFF. PATIENT WAS REVISED AND STEM WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 METASUL HEAD 32, 12/14, SIZE XXL/+10.5 DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2539942

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| O