BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ZIMMER KNEE INSTRUMENT

    MDR report key: 2844280 · Received November 8, 2012

    Report

    Report Number
    1822565-2012-02304
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Report Date
    October 9, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A HEALTH PROFESSION WHO IS NOT REQUIRED TO COMPLETE A FORM 3500A. EVALUATION SUMMARY: NEITHER SURGICAL NOTES NOR X-RAYS WERE PROVIDED, THEREFORE, FIT AND ORIENTATION COULD NOT BE EVALUATED. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOG IMPACT VS HIGH IMPACT) ARE UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVALUATION CODES: 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 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 ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON HAS EXPERIENCED PERFORATION OF THE TIBIAL HOME DURING PREPARATION OF THE KNEE FOR TOTAL ARTHROPLASTY AN UNK NUMBER OF TIMES. A SMALL AMOUNT OF BONE CEMENT WAS NOTED OUTSIDE OF THE TIBIA, INDICATING A SMALL PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER KNEE INSTRUMENT KNEE INSTRUMENT JDI ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1