BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN STAR ANKLE

    MDR report key: 8048491 · Received November 7, 2018

    Report

    Report Number
    0008031020-2018-00957
    Event Type
    Death
    Date Received
    November 7, 2018
    Date of Event
    April 8, 2010
    Report Date
    November 7, 2018
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE DISPOSITION IS UNKNOWN.

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF AN IMPLANT SUMMARY REPORT FROM (B)(6). THIS (B)(6) WAS PRODUCED ON (B)(6) 2018 AND IS ASSOCIATED WITH ¿STAR ANKLE¿. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN APRIL 2010 AND MAY 2018. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE OR PATIENT INFORMATION FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY, THEREFORE 22 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE STUDY. THIS PRODUCT INQUIRY ADDRESSES DEATH. 5 OUT OF 13 CASES. HOWEVER THE CAUSE AND THE DATE OF THE DEATH WILL NOT BE DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887717 UNKNOWN STAR ANKLE PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death