BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN M/G UNI TIBIAL PLATE

    MDR report key: 2133618 · Received June 16, 2011

    Report

    Report Number
    1822565-2011-01426
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT WAS REPORTED THAT THE ORIGINAL IMPLANTATION WAS 20+ YEARS AGO. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. IN GENERAL, PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. A DEFINITIVE ROOT CAUSE FOR THE ALLEGED TIBIAL PLATE FAILURE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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 INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED DUE TO FRACTURE OF THE TIBIAL PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN M/G UNI TIBIAL PLATE KNEE PROSTHESIS JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention