BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOHNSON & JOHNSON ORTHOPAEDICS

    MDR report key: 440416 · Received January 29, 2003

    Report

    Report Number
    440416
    Event Type
    Malfunction
    Date Received
    January 29, 2003
    Date of Event
    January 14, 2003
    Report Date
    January 28, 2003
    Manufacturer
    DEPUY
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR ON 4/14/2003: DEPUY BECAME AWARE OF THIS EVENT ON FEBRUARY 3, 2003. A COMPLAINT RECORD WAS CREATED, AND THE MDR DECISION TREE WAS COMPLETED. PER CO'S MDR PROCEDURE, THIS EVENT WAS DETERMINED TO BE NOT-REPORTED, FOR THE REASON THAT HIP DISLOCATION IS NOT GENERALLY ATTRIBUTABLE TO THE DESIGN OF THE IMPLANT. DEPUY DID NOT SUBMIT A MEDWATCH FORM REGARDING THIS EVENT.

    Description of Event or Problem · 1

    PT UNDERWENT SROM TOTAL HP ARTHROPLASTY IN 00. EARLY ON AFTER THE SURGERY, THE PT DEVELOPED SUBLUXATION EPISODES, THEN DEVELOPED THE FIRST OF FOUR DISLOCATIONS OF THE HIP IN 02. RECENTLY THE HIP SUBLUXATES WITH ORDINARY DAILY ACTIVITIES. PT UNDERWENT A TOTAL LEFT HIP ARTHROPLASTY IN 03. THE PT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOHNSON & JOHNSON ORTHOPAEDICS S-ROM SCREW, 5.0MM DIA HWC DEPUY 45MM LG 693128
    2 JOHNSON & JOHNSON ORTHOPAEDICS S-ROM LINER L SERIES, 10 DEG KWB DEPUY 28MM 584308
    3 JOHNSON & JOHNSON ORTHOPAEDICS S-ROM FEMORAL HEAD (HIP BALL) KWY DEPUY COCR 28+0 SA110511

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other