BEUDAMED
    FDA Adverse Event Other Summary report: N

    ROTALOK CUP

    MDR report key: 41152 · Received September 13, 1996

    Report

    Report Number
    1056629-1996-09001
    Event Type
    Other
    Date Received
    September 13, 1996
    Date of Event
    August 19, 1996
    Report Date
    September 12, 1996
    Manufacturer
    CORIN MEDICAL LTD
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MFR RECALLED CUP INSERTS FOR A SUSPECTED SPECIFICATION VARIANCE. THE DEVICE HAS NOT BEEN SOLD OR MARKETED IN THE US SINCE 12/94. TWELVE (12) COMPONENTS EXISTED IN THE US AS FOLLOWS: 4 AT CO AND 8 AT A HOSP ON LONG TERM LOAN. ALL COMPONENTS WERE RECOVERED AND QUARANTINED AWAITING FURTHER INSTRUCTIONS FROM MFR. ALL DEVICES WILL BE DESTROYED FOLLOWING INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTALOK CUP Implant ACETABULAR IMPLANT KWA CORIN MEDICAL LTD NA 041,938,317,840,412,102,589,95

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other