BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE POSTERIOR STABILIZED TIBIAL INSERT

    MDR report key: 41190 · Received September 9, 1996

    Report

    Report Number
    1043534-1996-00002
    Event Type
    Malfunction
    Date Received
    September 9, 1996
    Date of Event
    August 12, 1996
    Report Date
    September 9, 1996
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY POST OP X-RAYS AT ORIGINAL SURGERY SHOWED INSERT IN PLACE BUT 6 WKS POST OP X-RAY ALLEGEDLY SHOW INSERT IS NOT SEATED. PT WAS SYMPTOM FREE. PHYSICIAN WILL RECHECK IN 5 WEEKS AND FURTHER EVALUATE AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE POSTERIOR STABILIZED TIBIAL INSERT Implant KNEE COMPONENT JWH WRIGHT MEDICAL TECHNOLOGY, INC. NA 056A045313

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other