BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER, INC.

    MDR report key: 831 · Received July 1, 1992

    Report

    Report Number
    32578-1992-00002
    Event Type
    Injury
    Date Received
    July 1, 1992
    Report Date
    June 15, 1992
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    DC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD AN IB II IMPLANT ON 9/21/89. THE PATIENT SUBSEQUENTLY SUFFERED A TRAUMA WHICH RESULTED IN FRACTURE OF THE FEMUR AND FAILURE OF KNEE COMPONENTS. A REVISION SURGERY IN 2 STAGES WAS PREFORMED. INITIALLY, ON 3/17/92 THE PRIMARY FEMORAL COMPONENT WAS REMOVER AND A TEMPORARY SPACER MADE OF PMMA WAS IMPLANTED. SECOND SURGERY WAS AGAIN PERFORMED ON 6/12/92 TO REMOVE SPACER OF PMMA AND ORIGINAL TIBIAL ARTICULATING SURFACE AND TO RE-IMPLANT A CUSTOM FEMORAL COMPONENT AND NEW POLY TIBIAL SURFACEDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER, INC. Implant INSALL/BURSTEIN II MODULAR KNEE SYSTEM, PSK HSH ZIMMER, INC. N/A 65536200;7190100;67724900,ETC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention