BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/57MM

    MDR report key: 6947831 · Received October 13, 2017

    Report

    Report Number
    3003506883-2017-10234
    Event Type
    Injury
    Date Received
    October 13, 2017
    Report Date
    September 26, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    UDI-DI
    10886982166852
    PMA / PMN Number
    K011335
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HEIGHT REPORTED AS (B)(6) CENTIMETERS. ADDITIONAL PATIENT IDENTIFIER: (B)(6). PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED. BASED ON THE INFORMATION AVAILABLE, 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. UPON REVIEW OF THE X-RAYS THAT WERE PROVIDED, AN INVESTIGATION CANNOT BE PERFORMED AS THE COMPLAINT CONDITION CANNOT BE DETECTED. 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

    DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PRODUCT MANUFACTURED IN (B)(4) : PRODUCT MANUFACTURE DATE: 22-MAR-2016. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED NO COMPLAINT RELATED ANOMALIES. THE DHR SHOWS THIS LOT OF LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/57MM (PART NUMBER 241.351, LOT NUMBER H060671) WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCES OR REWORK NOTED. THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED 1 NC WAS INITIATED IN ETQ AGAINST THIS LOT OF MATERIAL FOR DEBRIS ON THE SURFACE OF THE RAW MATERIAL. THE NC WAS NOT CONFIRMED DURING THE EVALUATION PHASE SINCE THE LIGHT DEBRIS WAS NOTHING DETRIMENTAL TO THE PRODUCT USE. DUE TO THE FACT THAT THIS NONCONFORMANCE WOULD NOT AFFECT THE FINISHED PRODUCT, THIS NC HAD NO ADVERSE EFFECT ON THIS COMPLAINT. 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 DURING A SECOND REVISION SURGERY TO TREAT BICONDYLAR PROXIMAL TIBIA FRACTURE OF LEFT LEG, PATIENT UNDERWENT HARDWARE REMOVAL. THE FRACTURE DID NOT HEAL AS EXPECTED AND THE PATIENT PRESENTED NON-UNION. DUE TO THIS REASON, THIS SECOND REVISION SURGERY WAS PERFORMED. A TOTAL OF THREE (3) PLATES AND EIGHTEEN (18) SCREWS WERE REMOVED. ONE (1) PLATE WAS RETAINED WITHIN THE PATIENT. ALL THE IMPLANTS WERE REMOVED WITHOUT ANY DIFFICULTY AND WERE FOUND BE INTACT. THERE WAS NO REPORTED PRODUCT PROBLEM. THIS 2ND REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT WAS IMPLANTED WITH A COMPETITOR¿S DEVICE (TOTAL KNEE, STRYKER) AND IS REPORTED TO BE IN STABLE CONDITION. THIS COMPLAINT IS FOR TWENTY ONE (22) DEVICES. THIS REPORT IS 2 OF 22 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728306 LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/57MM PLATE,FIXATION,BONE HRS SYNTHES ELMIRA 241.351 H060671 10886982166852

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention