BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY TRI-LOCK LOW PROFILE TOTAL HIP CUP

    MDR report key: 5037 · Received June 17, 1993

    Report

    Report Number
    5037
    Event Type
    Malfunction
    Date Received
    June 17, 1993
    Date of Event
    May 10, 1993
    Report Date
    May 14, 1993
    Manufacturer
    DEPUY
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ON MAY 10, 1993, DR. REPLACED THE DEPUY TRI-LOCK LOW PROFILE TOTAL HIP CUP. IT HAD ORIGINALLY BEEN INSERTED IN 1984. THE DR. STATED THE ACETABULAR COMPONENT SHOWED WEAR SUPERIOR TOWARD THE DOME OF THE ONE PIECE OLD CEMENTED CUP. THE CEMENT WAS WELL ATTACHED TO THE POROUS COATED CUP.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE. CONCLUSION: OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY TRI-LOCK LOW PROFILE TOTAL HIP CUP Implant N/A LPH DEPUY N/A 810710B

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other