BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM-500 10 X 23, ANGLED, 8MM

    MDR report key: 4943402 · Received July 23, 2015

    Report

    Report Number
    3005751028-2015-00112
    Event Type
    Injury
    Date Received
    July 23, 2015
    Date of Event
    June 22, 2015
    Report Date
    September 28, 2015
    Manufacturer
    ZIMMER TRABECULAR METAL TECHNOLOGY
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE TM-500 IMPLANT DEVICE CRACKED DURING INSERTION. THERE WAS NO PATIENT OR USER HARM AND SURGICAL TECHNIQUE WAS FOLLOWED. SURGERY WAS DELAYED BY 20 MINUTES AND COMPLETED WITH ANOTHER DEVICE. THE DHR WAS REVIEWED AND NO ANOMALIES WERE FOUND. ALTHOUGH REQUESTED, THE DEVICE WAS NOT RETURNED TO ZIMMER (B)(4) FOR EVALUATION, NOR WAS ANY PHOTOGRAPHS OR EVIDENCE OF THE FRACTURED IMPLANT WAS RECEIVED; THEREFORE THIS FAILURE COULD NOT BE CONFIRMED. SHOULD ADDITIONAL INFORMATION BE OBTAINED TO FURTHER THIS INVESTIGATION, THIS REPORT SHALL BE UPDATED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN INSERTING THE TM-500, THE IMPACTING CAUSED THE DEVICE INSERTER HOLE TO BREAK CAUSING A CRACK IN THE POSTERIOR PORTION. THE DEVICE WAS THEN REMOVED BY DISTRACTING THE SCREWS AND A NEW DEVICE WAS INSERTED. THERE WAS NO REPORTED HARM TO THE PATIENT; HOWEVER, THE SURGERY WAS DELAYED 16-30 MINUTES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478655 TM-500 10 X 23, ANGLED, 8MM TM-500 MAX ZIMMER TRABECULAR METAL TECHNOLOGY 62430842

    Patients

    Seq Age Sex Outcome Treatment
    1