BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/80MM

    MDR report key: 3905265 · Received July 1, 2014

    Report

    Report Number
    2520274-2014-12234
    Event Type
    Injury
    Date Received
    July 1, 2014
    Report Date
    June 3, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JDP
    PMA / PMN Number
    PK110354
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. ADDITIONAL PRODUCT CODES: HRS AND HWC. IMPLANT DATE: UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 A PATIENT HAD A REVISION SURGERY FOR A DISTAL FEMUR NON-UNION AND THE HARDWARE WAS BROKEN SO IT WAS REMOVED. THE HARDWARE INCLUDED A 4.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE, 5.0MM VARIABLE ANGLE LOCKING SCREWS AND 5.0MM DYNAMIC LOCKING SCREWS. THE HARDWARE WAS REMOVED AND WASHED OUT. THE WOUND WAS THEN CLOSED. AFTER REVIEWING INTRAOPERATIVE X-RAYS, IT WAS DECIDED THAT A TOTAL KNEE REPLACEMENT WOULD BE BEST FOR THIS PATIENT. THE PATIENT WILL BE SEEN BY TOTAL JOINT SPECIALIST TO HAVE THE KNEE REPLACED AT A FUTURE DATE. NO SURGICAL DELAY WAS REPORTED. THIS IS REPORT 4 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382759 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/80MM IMPLANT, FIXATION DEVICE, CONDYLAR PLATE JDP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention