BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION FEMORAL STEM

    MDR report key: 8519 · Received January 24, 1994

    Report

    Report Number
    33532-1993-00025
    Event Type
    Injury
    Date Received
    January 24, 1994
    Date of Event
    December 6, 1993
    Report Date
    December 9, 1993
    Manufacturer
    HOWMEDICA, INC.
    Product Code
    JDD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A PRECISION STEM IMPLANTED IN 1988. IN 1992 HE STARTED COMPLAINING OF PAIN IN HIS HIP. X-RAY REVEALED A LOOSE STEM. REVISION OF THE STEM WAS CARRIEED OUT ON 12/6/93.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. 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: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION FEMORAL STEM Implant TOTAL HIP JDD HOWMEDICA, INC. VIEOA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention