BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES: TOMOFIX OSTEOTOMY

    MDR report key: 11520435 · Received March 18, 2021

    Report

    Report Number
    2939274-2021-01424
    Event Type
    Injury
    Date Received
    March 18, 2021
    Date of Event
    January 1, 2017
    Report Date
    February 18, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K: THIS REPORT IS FOR AN UNKNOWN PLATE TIBIAL MEDIAL HIGH TITANIUM 4 H AO TOMOFIX/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS AN ATTORNEY. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT ELECTIVE LEFT TOTAL KNEE ARTHROPLASTY SURGERY AND REMOVAL OF DEPUY SYNTHES TIBIAL PLATE AND SCREWS. RADIOGRAPHS REVEALED SEVERE DEGENERATIVE CHANGES OF THE JOINT AND WAS IMPLANTED WITH A NON-SYNTHES DEVICES. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) UNKNOWN PLATE TIBIAL MEDIAL HIGH TITANIUM 4 H AO TOMOFIX THIS IS REPORT 1 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415184 UNK - PLATES: TOMOFIX OSTEOTOMY PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention