BEUDAMED
    FDA Adverse Event Other Summary report: N

    MCMINN CUP

    MDR report key: 71892 · Received February 4, 1997

    Report

    Report Number
    1056629-1997-90001
    Event Type
    Other
    Date Received
    February 4, 1997
    Date of Event
    January 6, 1997
    Report Date
    February 3, 1997
    Manufacturer
    CORIN MEDICAL LTD
    Product Code
    KWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MFR RECALLED CUSTOMER RESURFACE IMPLANT DUE TO SUSPECTED PROBLEMS BETWEEN IMPLANT CUP HOLDER AND IMPLANT. 2 COMPONENTS EXIST (NON IMPLANTED) IN THE USA DEVICES TO BE RETURNED TO MFR FOR REWORK OR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCMINN CUP Implant ACETABULAR IMPLANT KWB CORIN MEDICAL LTD NA BMVQ/BPGZ

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other