BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER

    MDR report key: 827743 · Received March 9, 2007

    Report

    Report Number
    1822565-2007-00052
    Event Type
    Injury
    Date Received
    March 9, 2007
    Date of Event
    December 1, 2001
    Report Date
    February 12, 2007
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: CONDITION OF THE DEVICE IS NOT KNOWN. THE CAUSE FOR THE DISLOCATION COULD NOT BE DEFINITIVELY DETERMINED DUE TO INSUFFICIENT INFO. EVALUATION: PRODUCT AND X-RAYS WERE NOT RETURNED FOR EVALUATION. DEVICE HISTORY RECORDS INDICATE MANUFACTURE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2001. THE PT BEGAN TO FEEL AS THOUGH THE LEFT KNEE WAS A BIT LOOSE OR UNSTEADY, PARTICULARLY WHILE WALKING DURING THE DATE OF EVENT AND IN 2002. SIX MONTHS LATER, WHILE GETTING OUT OF HIS CAR, THE PT HAD AN ACUTE ONSET OF SEVERE PAIN IN THE LEFT KNEE AND FELT AS THOUGH PART OF HIS KNEE WAS STICKING OUT LATERALLY, AND DEVELOPED SWELLING IN THE JOINT. THE POLYETHYLENE ARTICULAR SURFACE HAD DISLOCATED. THE DEVICE WAS REVISED ON JULY 24, 2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER M/G UNI KNEE TIBIAL ART SURF HSH ZIMMER, INC. NA 72690000

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R