BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR CUP 47MM +0

    MDR report key: 353870 · Received September 17, 2001

    Report

    Report Number
    1722511-2001-00001
    Event Type
    Injury
    Date Received
    September 17, 2001
    Date of Event
    April 26, 2000
    Manufacturer
    ORTHO DEVELOPMENT CORP.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON AUGUST 1ST, 2000, ORTHO DEVELOPMENT RECEIVED A COMPLAINT FROM THE COMPANY'S DISTRIBUTOR IN JAPAN THAT STATED, "(T)HE INNER HEAD CAME OFF FROM THE OUTER CUP. THE (UHMW)PE LINER WAS FOUND TO BE WORN CONSIDERABLY BECAUSE OF IMPINGEMENT." THE BIPOLAR CUP INVOLVED WAS IMPLANTED IN 1998 INTO A PATIENT AND WAS EXPLANTED IN 2000. THE HIP PROSTHESIS (ORTHO DEVELOPMENT P/N 111-1117, LOT #W006135) THAT WAS MATED WITH THE BIPOLAR CUP WAS ALSO EXPLANTED; HOWEVER, THE HIP PROSTHESIS IS NOT A SUSPECT DEVICE IN THIS EVENT. PT CIRCUMSTANCES THAT RESULTED IN THE HEAD SEPARATING FROM THE CUP ARE UNKNOWN. THE BIPOLAR DEVICE AND HIP PROSTHESIS WERE REPLACED DURING THE EXPLANT SURGERY AND THE COMPANY'S DISTRIBUTOR IN JAPAN HAS NOT REPORTED ANY PROBLEMS REGARDING THIS PATIENT SINCE THAT EVENT. THE LATEST UPDATE FROM THE COMPANY'S DISTRIBUTOR REGARDING THIS PATIENT WAS RECEIVED IN 2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42395 BIPOLAR CUP 47MM +0 BIPOLAR ACETABULAR CUP KWY ORTHO DEVELOPMENT CORP. NA W002764

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R