BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER, INC.

    MDR report key: 1518 · Received October 5, 1992

    Report

    Report Number
    32578-1992-00006
    Event Type
    Injury
    Date Received
    October 5, 1992
    Date of Event
    September 9, 1992
    Report Date
    September 17, 1992
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING ITEMS WERE IMPLANTED ON 9/9/92: CENTRALIGN TOTAL HIP COMPONENT, HARRIS/GALANTE II POROUS ACETABULAR SHELL, POLY LINER. THE PHYSICIAN POSITIONED THE HARRIS/GALANTE II POROUS CUP USING THE PROPER INSTRUMENTATION. THE SURGEON WAS SATISFIED WITH THE STABILITY AND FIT OF THE COMPONENTS. THE POST-OP X-RAYS SHOWED THE CUP WAS MALPOSITIONED AND LATER THAT EVENING THE PATIENT'S HIP DISLOCATED. ON FRIDAY THE 11TH, THE PATIENT WAS BROUGHT BACK INTO SURGERY WHERE THE HARRIS/GALANTE II POROUS CUP WAS REMOVED AND A TI-BAC II CEMENTED CUP WAS IMPLANTED. THE PHYSICIAN DID A RANGE OF MOTION WITH THE NEWLY IMPLANTED ACETABULAR CUP AND FELT THAT THE HIP WAS STABLE. POST-OPERATIVE X-RAYS CONFIRMED THE CORRECT POSITION OF THE CUPDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT 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.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER, INC. Implant CENTRALIGN TOTAL HIP & HARRIS/GALANTE CUP MBL ZIMMER, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention