BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER UNICOMPARTMENTAL FEMORAL COMPONENT

    MDR report key: 2100552 · Received May 17, 2011

    Report

    Report Number
    1822565-2011-01192
    Event Type
    Injury
    Date Received
    May 17, 2011
    Report Date
    April 19, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: RETURNED FOR EVAL ARE TWO SETS OF X-RAYS. THE FIRST SET WAS TAKEN ON (B)(6) 2010 AND THE SECOND SET WAS TAKEN ON (B)(6) 2011. IN THE EARLIER SET OF X-RAYS, THERE APPEARS TO BE SOME RADIOLUCENCIES ON THE POSTERIOR AND DISTAL PORTIONS OF THE BONE/IMPLANT INTERFACE. THESE RADIOLUCENCIES ARE MORE PROMINENT IN THE LATER SET OF X-RAYS. IF THESE WERE IN FACT RADIOLUCENCIES, THE FORCES SEEN BY THE IMPLANT WOULD HAVE BEEN DIFFERENT THAN WHAT IT WAS DESIGNED TO SEE. THESE EXTRA FORCES COULD HAVE CAUSED EXCESS STRESS IN THE FRACTURE SITE WHICH COULD HAVE LED TO THE BREAKAGE OF THE IMPLANT. THE FEMUR ALSO APPEARS TO BE SLIGHTLY OVERSIZED. IN THE BOTH SETS OF X-RAYS, THE ANTERIOR PORTION OF THE IMPLANT IS NOT IN CONTACT WITH THE BONE. WITH THE LIMITED AMOUNT OF INFO AVAILABLE, IT CANNOT BE DETERMINED WHAT CAUSED THE FRACTURE OF THE IMPLANT. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT ON X-RAY, THE FEMORAL COMPONENT APPEARS TO HAVE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER UNICOMPARTMENTAL FEMORAL COMPONENT HSX ZIMMER, INC. 60288669

    Patients

    Seq Age Sex Outcome Treatment
    1 Other