BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HGP I CUSTOM LINER

    MDR report key: 8701 · Received March 11, 1994

    Report

    Report Number
    34538-1994-00002
    Event Type
    Malfunction
    Date Received
    March 11, 1994
    Date of Event
    January 26, 1994
    Report Date
    February 3, 1994
    Manufacturer
    ZIMMER
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY ON 1/26/94 THE CUSTOM LINER FAILED TO MATE WITH ITS INTENDED 58MM HGP I ACETABULAR SHELL PRESENTLY IMPLANTED IN THE PT. THE CUSTOM LINER WAS TOO LARGE FOR THE EXISTING SHELL AND A STANDARD HGP II LINER HAD TO BE IMPLANTED INSTEAD.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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.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: YES. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HGP I CUSTOM LINER Implant LINER KWA ZIMMER HGP I LINER

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other