BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE 131MM

    MDR report key: 10395350 · Received August 12, 2020

    Report

    Report Number
    2939274-2020-03481
    Event Type
    Injury
    Date Received
    August 12, 2020
    Report Date
    July 21, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982028976
    PMA / PMN Number
    K052677
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). INVESTIGATION SUMMARY. 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 HISTORY. PART NUMBER: 02.102.001. LOT NUMBER: 9944571. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 28. JUNE 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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) 2020 THE PATIENT UNDERWENT REMOVAL OF DYNAMIC HELICAL HIP SYSTEM (DHHS) FOLLOWED BY CONVERSION OF TOTAL HIP REPLACEMENT. THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE DHHS SYSTEM ON AN UNKNOWN DATE. THE PROCEDURE AND PATIENT OUTCOMES ARE UNKNOWN. THIS IS REPORT 3 OF 10 FOR (B)(4). THIS REPORT IS FOR A LOCKING TROCHANTERIC STABILIZATION PLATE. (B)(4) IS LINKED TO THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859804 UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE 131MM PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 02.102.001 9944571 10886982028976

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 130 DEG LCP® DHHS(TM) SIDEPLATE-4 HOLES| HELIX BLADE 100MM| UNK - SCREWS: CORTEX| UNK - SCREWS: CORTEX| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING