BEUDAMED
    FDA Adverse Event Injury Summary report: N

    P.F.C. BIPOLAR HEAD LINER COMPONENT

    MDR report key: 77930 · Received March 25, 1997

    Report

    Report Number
    1219655-1997-00057
    Event Type
    Injury
    Date Received
    March 25, 1997
    Date of Event
    January 25, 1997
    Report Date
    March 25, 1997
    Manufacturer
    JOHNSON & JOHNSON PROFESSIONAL, INC.
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS DIMENSIONALLY INSPECTED AND THE DIMENSIONS WHICH CONTROL THE ENGAGMENT OF THE LOCKING LIP WERE FOUND TO MEET SPECIFICATION REQUIREMENTS. THE MANUFACTURING BATCH HISTORY RECORDS WERE REVIEWED AND FOUND TO BE IN COMPLIANCE. UNABLE TO DETERMINE REASON FOR DISASSOCIATION. NO FURTHER INVESTIGATION IS PLANNED. MEDWATCH REPORT NO. 62441-1011100 WAS RECEIVED BY JJPI IN APRIL 1997. THIS EVENT WAS REPORTED TO THE FDA BY JJPI ON MARCH 25, 1997, PRIOR TO RECEIPT OF THE USER FACILITY REPORT. USER FACILITY REPORT 62441-1011100 IDENTIFIES FEMORAL HEAD 60727, LINER 57194, SHELL 57775, AND STEM 57245. THE FEMORAL HEAD IS THE SUBJECT OF MFG MEDWATCH REPORT 1219655-1997-00058. THE LINER IS THE SUBJECT OF THE MFG MEDWATCH REPORT 1219655-1997-00057. THE SHELL AND STEM DEVICES DID NOT CONTRIBUTE TO THIS EVENT AND ARE NOT BEING FILED AS MDR'S. ADDITIONALLY, NUMBERS IDENTIFIED BY THE USER FACILITY ARE LOT CODES AND ARE NOT CATALOG NUMBERS.

    Description of Event or Problem · 1

    BIPOLAR LINER COMPONENT 85-8206 AND FEMORAL HIP HEAD COMPONENT 85-3834, SUBJECT OF MEDWATCH MFG REPORT #1219655-1997-00058 AND THE SAME FIRM CONTROL NUMBER 97R00537, WERE REVISED DUE TO DISASSOCIATION OF THE LINER COMPONENT FROM THE FEMORAL HIP HEAD COMPONENT. NO OTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 P.F.C. BIPOLAR HEAD LINER COMPONENT Implant BIPOLAR LINER COMPONENT KWB JOHNSON & JOHNSON PROFESSIONAL, INC. NA 57194

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention