BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 7669420 · Received July 9, 2018

    Report

    Report Number
    2939274-2018-52734
    Event Type
    Injury
    Date Received
    July 9, 2018
    Report Date
    June 11, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS UNKNOWN. DATE OF EVENT IS UNKNOWN DATE PRIOR TO 2009. THIS REPORT IS FOR AN UNKNOWN PROXIMAL FEMORAL LOCKING PLATE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DATE OF IMPLANTATION IS UNKNOWN. DEVICE WAS NOT EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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. 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: MCMICHAEL J, MOED B ET AL (2009). FAILURE OF INTERTROCHANTERIC FIXATION USING A LOCKING PLATE: A CASE REPORT. CURRENT ORTHOPAEDIC PRACTICE. VOLUME 20. NUMBER 1. (USA). THIS CASE REPORT ILLUSTRATES A DEPARTURE FROM TRADITIONAL INTERTROCHANTERIC FRACTURE MANAGEMENT AND HIGHLIGHTS POSSIBLE LIMITATIONS OF LOCKED INTERNAL FIXATION IN THIS SETTING. THIS IS A CASE REPORT OF AN (B)(6)-YEAR-OLD WOMAN WHO PRESENTED TO THE EMERGENCY DEPARTMENT AFTER SLIPPING AND FALLING ON HER LEFT SIDE. THE PATIENT NOTICED IMMEDIATE LEFT HIP PAIN. ANTEROPOSTERIOR AND LATERAL RADIOGRAPHS OF THE LEFT HIP SHOWED A 31-A2.2 INTERTROCHANTERIC FEMORAL FRACTURE. ON THE THIRD HOSPITAL DAY, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF HER LEFT PROXIMAL FEMORAL STRUCTURE AND WAS IMPLANTED WITH A SEVEN-HOLE UNKNOWN SYNTHES PROXIMAL FEMORAL LOCKING PLATE. ON THE SECOND POST-OPERATIVE DAY, THE PATIENT WAS ABLE TO STAND WITH MAXIMAL ASSISTANCE FROM PHYSICAL THERAPY WITH THE PLAN TO PROGRESS TO WEIGHT BEARING AS TOLERATED. PATIENT¿S SUBSEQUENT HOSPITAL COURSE WAS COMPLICATED BY RIGHT COLONIC ISCHEMIA REQUIRING A RIGHT HEMICOLECTOMY, NEW ONSET ATRIAL FIBRILLATION, ACUTE RENAL FAILURE, PNEUMONIA, URINARY TRACT INFECTION AND CLOSTRIDIUM DIFFICILE COLITIS, WHICH FURTHER DELAYED PHYSICAL REHABILITATION. 12 DAYS POST-OP, ANTEROPOSTERIOR AND LATERAL RADIOGRAPHS OF THE LEFT HIP SHOWED VARUS MALALIGNMENT OF THE FRACTURE. AN ANTEROPOSTERIOR RADIOGRAPH OBTAINED JUST BEFORE TRANSFER DEMONSTRATED FURTHER PROGRESSION OF THE VARUS MALALIGNMENT AND FAILURE OF THE LOCKING PLATE. PATIENT DID NOT PRESENT FOR ANY POSTOPERATIVE CLINIC VISITS, AND EXPIRED APPROXIMATELY 1 MONTH AFTER HOSPITALIZATION NEVER HAVING RETURNED TO AN AMBULATORY STATUS. THIS REPORT IS FOR AN UNKNOWN SYNTHES PROXIMAL FEMORAL LOCKING PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513861 PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention