BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER UNICOMPARTMENTAL TIBIAL COMPONENT

    MDR report key: 3201681 · Received June 28, 2013

    Report

    Report Number
    1822565-2013-01040
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    December 14, 2007
    Report Date
    May 29, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY - THE IMPLANTED COMPONENTS WERE CONFIRMED AS COMPATIBLE. THE PRIMARY OPERATIVE NOTES PROVIDED WERE REVIEWED WITH NO SIGNIFICANT FINDINGS. THE REVISION OPERATIVE NOTES STATE THAT THE TIBIAL COMPONENT WAS FOUND TO BE LOOSE. NO OTHER OBSERVATIONS REGARDING CONDITION OF IMPLANTS DURING THE REVISION SURGERY WERE MADE, AND NO DEVICES OR PHOTOS WERE RECEIVED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. 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 WAS REPORTED THAT THE PT UNDERWENT REVISION SURGERY AND THAT DURING REVISION, THE TIBIAL COMPONENT WAS NOTED AS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296680 ZIMMER UNICOMPARTMENTAL TIBIAL COMPONENT HSX ZIMMER, INC. 60623194

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention