BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER TIBIAL INSERT

    MDR report key: 2010517 · Received March 1, 2011

    Report

    Report Number
    1822565-2011-00436
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    June 21, 2010
    Report Date
    February 1, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PT UNDERWENT BILATERAL REVISION APPROX 22 YEARS POST-OP. THE RETURNED COMPONENTS EXHIBIT SEVERE WEAR. THE SURFACE OF THE TIBIAL INSERT IS DISCOLORED, BOTH CONDYLES EXHIBIT EXTREME ABRASIVE WEAR, AND THE LOCKING MECHANISM HAS BEEN DAMAGED. ONLY ONE PATELLA BUTTON WITH UNK ITEM NUMBER AND LOT NUMBER WAS RETURNED; IT IS UNK WHICH KNEE THIS CAME FROM. THE PATELLA BUTTON ALSO EXHIBITS SURFACE FATIGUE ON BOTH THE ANTERIOR AND POSTERIOR SURFACES AS WELL AS DISCOLORATION OF THE MATERIAL. IT WAS REPORTED THAT THERE WAS NO OSTEOLYSIS OF THE BONE, AND THAT THERE WAS ONLY SYNOVIAL INFLAMMATION. NEITHER X-RAYS NOR OP-NOTES WERE PROVIDED. THE MOST LIKELY CAUSE OF THIS IS 22 YEARS OF NORMAL WEAR. WITHOUT ADD'L INFO, THE EXACT CAUSE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT LEFT KNEE REVISION OF TIBIAL INSERT AND PATELLA COMPONENT DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER TIBIAL INSERT KNEE PROSTHESIS JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention ZIMMER PATELLA BUTTON, CATALOG # UNK, LOT # UNK