BEUDAMED
    FDA Adverse Event Injury Summary report: N

    P.C.A HIP SYSTEM ACETABULAR INSERT SIZE D 32MM/D

    MDR report key: 34703 · Received June 12, 1996

    Report

    Report Number
    34697-1996-00005
    Event Type
    Injury
    Date Received
    June 12, 1996
    Date of Event
    June 4, 1996
    Report Date
    June 11, 1996
    Manufacturer
    HOWMEDICA/DAVIS-COUPENS & ASSOC.
    Product Code
    KWD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    ID, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    WHEN SURGEON ATTEMPTED TO IMPLANT INSERT, IT FAILED TO ENGAGE OUTER SHELL. A NEW INSERT WAS OPENED AND DID ENGAGE SHELL.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER 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: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 P.C.A HIP SYSTEM ACETABULAR INSERT SIZE D 32MM/D ACETABULAR INSERT KWD HOWMEDICA/DAVIS-COUPENS & ASSOC. TFGKYA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention