BEUDAMED
    FDA Adverse Event Injury Summary report: N

    P.F.C. POROUS FEMORAL COMPONENT

    MDR report key: 43699 · Received October 22, 1996

    Report

    Report Number
    1219655-1996-00020
    Event Type
    Injury
    Date Received
    October 22, 1996
    Date of Event
    September 26, 1996
    Report Date
    October 15, 1996
    Manufacturer
    JOHNSON & JOHNSON PROFESSIONAL, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H3, H6 - A NON-DESTRUCTIVE EVAL WAS PERFORMED ON THE 86-4108 POROUS COATED FEMORAL KNEE COMPONENT. THE FEMORAL COMPONENT WAS RECEIVED AS TWO SEPARATE PIECES DUE TO FATIGUE FRACTURE OF THE MEDIAL CONDYLE AT THE POSTERIOR, DISTAL CHAMFER. THE FATIGUE STRIATIONS ON THE LATERAL SIDE APPEARED TO PROGRESS ACROSS THE FRACTURE SURFACE WHICH SUGGESTS THAT THE FRACTURE ORIGIN IS MOST LIKELY ON THE LATERAL SIDE. METALLOGRAPHIC EXAMINATION SHOWED EVIDENCE OF FATIGUE CRACK PROPOGATION BUT DID NOT REVEAL ANY EVIDENCE OF MATERIAL OR MANUFACTURING DEFECTS. THE 2MM TO 3MM CEMENT MANTLE USED TO FIX THE FEMORAL COMPONENT SHOWED GOOD CEMENT PENETRATION INTO THE POROUS BEADED SURFACE EXCEPT ON THE MOST DISTAL FLAT BEADED SURFACE ON THE MEDIAL SIDE OF THE COMPONENT. IN SUMMARY, WHILE THE FAILURE MODE WAS ONE OF FATIGUE, INSUFFICIENT EVIDENCE WAS PRESENT TO DETERMINE THE EXACT CAUSE OF THE FAILURE. NO MATERIAL OR MANUFACTURING DEFECTS WERE SEEN ON THE COMPONENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED FOLLOWING APPARENT FRACTURE OF A POSTERIOR CONDYLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 P.F.C. POROUS FEMORAL COMPONENT Implant FEMORAL COMPONENT, POROUS COATED JWH JOHNSON & JOHNSON PROFESSIONAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention