BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP PERIARTICULAR PROX HUMERUS PL 4 HOLE/127MM/RT

    MDR report key: 8004758 · Received October 25, 2018

    Report

    Report Number
    2939274-2018-54600
    Event Type
    Injury
    Date Received
    October 25, 2018
    Report Date
    October 10, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982042071
    PMA / PMN Number
    K082625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 02.123.022, LOT: 7953204. MANUFACTURING LOCATION: ELMIRA, MANUFACTURING DATE: MAR 19, 2015. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED NO NONCONFORMANCES. THE DHR SHOWS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NONCONFORMANCES OR REWORK NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED. (B)(4). 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 AN UNKNOWN DATE, THE PATIENT UNDERWENT HARDWARE REMOVAL OF ONE (1) PERIARTICULAR PROXIMAL HUMERUS PLATE, THREE (3) UNKNOWN CORTEX SCREWS AND EIGHT (8) UNKNOWN LOCKING SCREWS DUE TO PAIN. THE HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2017. ALL HARDWARE WAS SUCCESSFULLY REMOVED WITH NO ISSUES. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 3.5MM LOCKING COMPRESSION PLATE (LCP). THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847094 3.5MM LCP PERIARTICULAR PROX HUMERUS PL 4 HOLE/127MM/RT PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 02.123.022 7953204 10886982042071

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention