BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5 VA-LCP CRVD COND PL/12 HOLE/266/LFT

    MDR report key: 14654053 · Received June 10, 2022

    Report

    Report Number
    2939274-2022-02204
    Event Type
    Injury
    Date Received
    June 10, 2022
    Date of Event
    May 16, 2022
    Report Date
    June 10, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDP
    UDI-DI
    10886982042873
    PMA / PMN Number
    K110354
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J EMPLOYEE. PART # 02.124.413. LOT NUMBER: 85P1799. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 19 JAN 2021. SUPPLIER: WRIGHTS LANE SYNTHES USA PRODUCTS LLC. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 · 0

    IT WAS REPORTED THAT ON (B)(6) 2022 THERE WAS A REMOVAL OF THE VARIABLE ANGLE (VA) CONDYLE PLATE AND CORRESPONDING SCREWS DUE TO NONUNION/MALUNION. THE SURGEON REMOVED THE PLATE AND SCREWS, REALIGNED THE FEMUR, INSERTED IM NAIL, AND INSERTED BONE GRAFT OBTAINED VIA RADIOIMMUNOASSAY (RIA) PROCEDURE. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR (1) 4.5 VA-LCP CRVD COND PL/12 HOLE/266/LFT. THIS IS REPORT 1 OF 12 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2421192 4.5 VA-LCP CRVD COND PL/12 HOLE/266/LFT IMPLANT, FIXATION DEVICE, CONDYLAR PLATE JDP WRIGHTS LANE SYNTHES USA PRODUCTS LLC 02.124.413 85P1799 10886982042873

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male Required Intervention 4.5MM CORTEX SCREW SELF-TAPPING 32MM| 4.5MM CORTEX SCREW SELF-TAPPING 32MM| 4.5MM CORTEX SCREW SELF-TAPPING 32MM| 5.0 VA LCK SCRW/S/TAP /80| 5.0 VA LOCKNG SCR SLF-TPNG/SD/80| 5.0 VA LOCKNG SCR SLF-TPNG/SD/80| 5.0 VA LOCKNG SCR SLF-TPNG/SD/80| 5.0 VA LOCKNG SCR SLF-TPNG/SD/80| 5.0 VA LOCKNG SCR SLF-TPNG/SD/80| 5.0 VA LOCKNG SCR SLF-TPNG/SD/80| CORTSCR Ø4.5 SELF-TAP L32 SST