BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ZIMMER KNEE

    MDR report key: 1062604 · Received June 18, 2008

    Report

    Report Number
    1822565-2008-00335
    Event Type
    Injury
    Date Received
    June 18, 2008
    Report Date
    May 21, 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. EVALUATION SUMMARY: NO PRODUCT RECEIVED FOR EVALUATION. ALSO, X-RAYS ARE NOT AVAILABLE FOR REVIEW. ITEM NUMBER AND LOT NUMBER OF THE DEVICE ARE NOT KNOWN SO DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. IT IS REPORTED THAT THE SURGEON USUALLY CEMENTS ONLY THE BASE PLATE AND NOT DOWN THE STEM EXTENSION. WHILE THE RECOMMENDED CEMENTING TECHNIQUE IS - "WHEN USING THE MIS DROP DOWN EXTENSIONS, IT IS NECESSARY TO APPLY BONE CEMENT DOWN THE CANAL TO ENSURE SOLID INTRAMEDULLARY FIXATION AROUND THE EXTENSION." THE CAUSE OF THE PROBLEM COULD NOT BE DEFINITELY DETERMINED, HOWEVER, THE INCORRECT CEMENTING TECHNIQUE APPEARS TO BE THE CAUSE OF TIBIAL PLATE LOOSENING. EVALUATION: 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 ADDITIONAL 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 OCCURRED FOR LOOSENING. EXACT IMPLANT AND EXPLANT DATES ARE UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R