BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ZIMMER SEGMENTAL KNEE

    MDR report key: 1020354 · Received March 27, 2008

    Report

    Report Number
    1822565-2008-00129
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE COULD NOT OBTAIN A COMPLETE CATALOG NUMBER, THEREFORE, A BASELINE REPORT CANNOT BE FILED. EVAL SUMMARY: SUBLUXATION OF THE KNEE, ASSUMING THIS IS SEPARATION OF THE SEGMENTAL HINGE POST PORTION SHANK FROM THE TIBIAL COMPONENT, COULD POSSIBLY BE CAUSED BY EXCESSIVE LAXITY IN THE SOFT TISSUE STRUCTURES ABOUT THE KNEE AND/OR USE OF A SEGMENTAL ARTICULAR SURFACE POLYETHYLENE COMPONENT THAT IS NOT THICK ENOUGH TO COMPENSATE FOR EXCESSIVE SOFT TISSUE LAXITY. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT REVISION SURGERY WAS PERFORMED IN 2008, DUE TO SUBLUXATION OF THE KNEE AT FOUR WEEKS. A POLY/HINGE SWAP OUT WAS PERFORMED. NO IMPLANT FAILURE WAS FOUND BY THE DOCTOR, BUT HE DID FIND A BLOWN QUADRICEPS TENDON, WHICH HE REPAIRED. THE PT WAS WELL OVER 300 POUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK ZIMMER SEGMENTAL KNEE KNEE PROSTHESIS JWH ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R