BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER FEMORAL HEAD PROSTHESIS

    MDR report key: 7245 · Received November 5, 1993

    Report

    Report Number
    35175-1993-00004
    Event Type
    Injury
    Date Received
    November 5, 1993
    Date of Event
    October 12, 1993
    Report Date
    October 22, 1993
    Manufacturer
    ZIMMER
    Product Code
    JDD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DISCOVERED FOLLOWING SURGERY THAT WRONG SIZE FEMORAL HEAD (26MM) WAS IMPLANTED IN 28MM LINER THAT FIT INTO ACETABULAR SHELL. ADDITIONAL SURGERY PERFORMED TO IMPLANT CORRECT 28MM FEMORAL HEAD.DEVICE 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 NOT USED AS LABELED/INDENDED.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. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER FEMORAL HEAD PROSTHESIS Implant FEMORAL HEAD, MEDIUM NECK JDD ZIMMER 00705500

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention