BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER LPS FLEX ARTICULATING SURFACE

    MDR report key: 1012669 · Received March 12, 2008

    Report

    Report Number
    1822565-2008-00093
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    March 10, 2004
    Report Date
    February 11, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    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 THE LOT NUMBER OF THE DEVICE ARE NO KNOWN SO DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE CAUSE OF THE PROBLEM COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. 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 INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2004. REVISION SURGERY OCCURRED IN 2005, DUE TO BREAKAGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R