BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ARTICULAR SURFACE

    MDR report key: 2220268 · Received August 16, 2011

    Report

    Report Number
    1822565-2011-01886
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE RETURNED DEVICE EXHIBITS DELAMINATION TO THE POSTERIOR SIDE OF THE CONDYLE BEARING SURFACE. THE DEVICE ALSO EXHIBITS WEAR AND DEFORMATION DAMAGE TO THE POSTERIOR SIDE OF THE DEVICE. THE INFERIOR SURFACE OF THE DEVICE EXHIBITS WEAR AND THE ITEM / LOT NUMBERS ARE NOT VISIBLE; THEREFORE NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. THE DEVICE WAS AUTOCLAVED PRIOR TO RETURN TO ZIMMER; THEREFORE, NO DIMENSIONAL ANALYSIS COULD BE PERFORMED. NO X-RAYS WERE REC'D WITH THE COMPLAINT FOR REVIEW. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. 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 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 ADD'L SUBSTANTIVE INFO BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, (B)(4) CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN (B)(6) 1998 AND THAT THE PT WAS REVISED FOR OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ARTICULAR SURFACE KNEE PROSTHESIS JWH ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention