BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER

    MDR report key: 1900894 · Received November 9, 2010

    Report

    Report Number
    9610667-2010-00012
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Report Date
    November 10, 2010
    Manufacturer
    TORNIER, INC.
    Product Code
    KWS
    PMA / PMN Number
    994392
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFG RECORDS OF THE MATING COMPONENTS SHOW NO DEVIATION TO SPECIFICATIONS. THE RETURNED HUMERAL HEAD COMPONENT HAS BEEN EXAMINED AND IS FOUND WITHIN SPECIFICATIONS. CAUSE OF FAILURE IS CURRENTLY UNK BUT MAY BE DETERMINED SHOULD CLINICAL INFO BE RELEASED FOR REVIEW.

    Description of Event or Problem · 1

    IT IS REPORTED THAT AN AEQUALIS SHOULDER PROSTHESIS BECAME DISASSEMBLED APPROX 2.5 MONTHS AFTER INITIAL IMPLANTATION SURGERY. THE PATIENT REQUIRED REVISION SURGERY TO CORRECT THE ASSEMBLY OF THE IMPLANT. NO FURTHER PT OR CLINICAL INFO HAS BEEN ACQUIRED. THE DATES OF IMPLANT AND REVISION SURGERIES HAVE NOT BEEN IDENTIFIED. FURTHER CLINICAL INFO HAS BEEN REQUESTED. THE HUMERAL HEAD COMPONENT HAS BEEN RETURNED FOR EXAMINATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNIER PROSTHESIS, SHOULDER, SEMICONSTRAINED KWS TORNIER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R