BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC TOTAL HIP SYSTEM- FEMORAL HIP HEAD

    MDR report key: 111729 · Received August 11, 1997

    Report

    Report Number
    1219655-1997-00114
    Event Type
    Injury
    Date Received
    August 11, 1997
    Date of Event
    June 30, 1997
    Report Date
    August 6, 1997
    Manufacturer
    JOHNSON & JOHNSON PROFESSIONALS, INC.
    Product Code
    KWY
    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 EVENTS LEADING TO REVISION SURGERY, AS FOLLOWS. THE DISLOCATION OF THE INNDER HEAD FROM THE LINER OCCURRED AFTER AN ATTEMPT AT CLOSED REDUCTION, BUT WAS SECONDARY TO THE INITIAL FAILURE MODE WHICH WAS A DISLOCATION OF THE OUTER BIPOLAR HEAD FROM THE ACETABULUM DUE TO TRAUMA (FALLING). THIS TRAUMATIC EVENT CAN IN ITSELF INFLUENCE THE PERFORMANCE OF THE IMPLANT UNDER CLOSED REDUCTION. THE TRAUMATIC PRIMARY DISLOCATION, ACETABULAR ANATOMY AS WELL AS UNKNOWN JOINT LAXITY CAN INCREASE THE PROBABILTY OF THE SECONDARY DISSOCIATION OF THE INNER HEAD FROM BIPOLAR COMPONENT UNDER CLOSED REDUCTION ATTEMPTS. IN SUMMARY, THE TOTAL INFO AVAILABLE DOES NOT INDICATE THAT A DEFECTIVE DEVICE WAS THE CAUSE FOR THE PRIMARY DISLOCATION OF PROSTHESIS. THE DISLOCATION CANNOT BE ATTRIBUTED TO A DEFECTIVE COMPONENT, WHILE THE SECONDARY DISSOCIATION OF FEMORAL HEAD FROM BIPOLAR COMPONENT NECESSITATING REVISION HIP SURGERY AFTER PRIMARY DISLOCATION MAY STEM FROM IMPINGEMENT AND AN EXCESSIVE OVERLOAD DURING CLOSED REDUCTION, AND POSSIBLY TO THE TRAUMA WHICH CAUSED OUTER POLE'S INITIAL DISLOCATION.

    Description of Event or Problem · 1

    PT FELL DISLOCATING IMPLANT, LINER/SHELL ASSEMBLY AND HIPHEAD DISASSOCIATED DURING CLOSED REDUCTION. REVISION SURGERY WAS NECESSARY WHEN THE 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- FEMORAL HIP HEAD Implant PROSTHETIC HIP KWY JOHNSON & JOHNSON PROFESSIONALS, INC. NA 64357

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention PFC BIPOLAR LINER, CAT. #85-1208, LOT # 304784,| PFC ACETABULAR SHELL, CAT#85-8252, LOT #49198.