BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA 32MM STD FEMORAL HEAD

    MDR report key: 7234 · Received October 14, 1993

    Report

    Report Number
    33462-1993-01102
    Event Type
    Injury
    Date Received
    October 14, 1993
    Date of Event
    August 17, 1993
    Report Date
    September 3, 1993
    Manufacturer
    HOWMEDICA, INC.
    Product Code
    JDD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    UNKNOWNDEVICE 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: NO DATA. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA 32MM STD FEMORAL HEAD Implant SAB JDD HOWMEDICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention