BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER KNEE IMPLANT

    MDR report key: 2963413 · Received February 13, 2013

    Report

    Report Number
    1822565-2013-00299
    Event Type
    Injury
    Date Received
    February 13, 2013
    Report Date
    January 15, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNK. 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 (LOW IMPACT VS. HIGH IMPACT) ARE UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL 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 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. 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 THE PT IS EXPERIENCING KNEE PAIN, SWELLING, BREAKOUT OF THE SKIN, AND POSSIBLE ALLERGY TO THE METAL IN THE KNEE COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63766 UNKNOWN ZIMMER KNEE IMPLANT KNEE PROSTHESIS JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other