BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC TOTAL HIP SYSTEM- BIPOLAR LINER

    MDR report key: 111735 · Received August 11, 1997

    Report

    Report Number
    1219655-1997-00113
    Event Type
    Injury
    Date Received
    August 11, 1997
    Date of Event
    June 30, 1997
    Report Date
    August 11, 1997
    Manufacturer
    JOHNSON & JOHNSON PROFESSIONALS, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED BY JJPI ON 7/14/97 AND FORWARDED TO OUR UK FACILITY FOR EVAL. MFG RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. A TECHNICAL REVIEW WAS ALSO PERFORMED BY JJPI'S HIP R AND D GROUP. POST RETRIEVAL ANALYSIS REVEALED NO ABNORMALITIES IN DIMENSION AND WERE WITHIN MFG SPECIFICATIONS. TECHNICAL REVIEW HAS PROVIDED ANALYSIS OF RADIOGRAPHS AND EVENT LEADING TO REVISION SUGERY, AS FOLLOWS. DISLOCATION OF INNER HEAD FROM LINER OCCURRED AFTER AN ATTEMPT AT CLOSED REDUCTION, BUT WAS SECONDARY TO INITIAL FAILURE MODE WHICH WAS A DISLOCATION OF OUTER BIPOLAR HEAD FROM ACETABULUM DUE TO TRAUMA (FALLING).THIS TRAUMATIC EVENT CAN IN ITSELF INFLUENCE PERFORMANCE OF IMPLANT UNDER CLOSED REDUCTION. TRAUMATIC PRIMARY DISLOCATION, ACETABULAR ANATOMY AS WELL AS UNKNOWN JOINT LAXITY CAN INCREASE PROBABILITY OF SECONDARY DISSOCIATION OF INNER HEAD FROM BIPOLAR COMPONENT UNDER CLOSED REDUCTION ATTEMPTS. IN SUMMARY, TOTAL INFO AVAILABLE DOES NOT INDICATE THAT DEFECTIVE DEVICE WAS CAUSE FOR PRIMARY DISLOCATION OF PROSTHESIS. DISLOCATION CANNOT BE ATTRIBUTED TO A DEFECTIVE COMPONENT, WHILE SECONDARY DISSOCIATION OF FEMORAL HEAD FROM BIPOLAR COMPONENT NECESSITATING REVISION HIP SURGERY AFTER PRIMARY DISLOCATION MAY STEM FROM IMPINGEMENT AND EXCESSIVE OVERLOAD DURING CLOSED REDUCTION, AND POSSIBLY TO TRAUMA WHICH CAUSED OUTER POLE'S INTITIAL DISLOCATION. JJPI CONDISERS THIS FILE TO BE CLOSED.

    Description of Event or Problem · 1

    PT FELL DISLOCATING IMPLANT, LINER/SHELL ASSEMBLY AND HIPHEAD DISASSOCIATED DURING CLOSED REDUCTION. REVISION SURGERY WAS NECESSARY WHEN CLOSED REDUCTION WAS UNSUCCESSFUL. THE FOLLOWING DEVICES: CAT# 85-1208, MDR #1219655-1997-00113, AND CAT# 85-3834, MDR # 1219655-1997-00114 ARE SUBJECT OF THE SAME JJPI INTERNAL REFERENCE #97R01489.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC TOTAL HIP SYSTEM- BIPOLAR LINER Implant PROSTHETIC HIP KWB JOHNSON & JOHNSON PROFESSIONALS, INC. NA 304784

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention PFC ACETABULAR SHELL, CAT#85-8252, LOT #49198.| PFC FEMORAL HIP HEAD, CAT.#85-3834, LOT #64357,