BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 8778172 · Received July 10, 2019

    Report

    Report Number
    2939274-2019-59111
    Event Type
    Injury
    Date Received
    July 10, 2019
    Report Date
    June 13, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN - PLATE-TRAUMA/UNKNOWN LOT NUMBER. WITHOUT THE SPECIFIC PART NUMBER, THE UDI NUMBER AND 510K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). THE REPORTED EVENT REQUIRED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE. AN (B)(6) YEAR OLD MALE EXPERIENCED HETEROTOPIC OSSIFICATION REQUIRING INTERVENTION. INVESTIGATION SUMMARY 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, 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: LIN C. ET AL (2015) FUNCTIONAL OUTCOMES AFTER TOTAL HIP ARTHROPLASTY FOR THE ACUTE MANAGEMENT OF ACETABULAR FRACTURES: 1- TO 14-YEAR FOLLOW-UP, JOURNAL OF ORTHOPAEDIC TRAUMA 2015 MARCH, VOLUME 29, NUMBER 3, PAGES 151-159 (USA). THIS RETROSPECTIVE STUDY REPORTS THE COMPLICATIONS AND FUNCTIONAL OUTCOMES IN PATIENTS TREATED ACUTELY WITH COMBINED OPEN REDUCTION INTERNAL FIXATION (ORIF) AND IMMEDIATE TOTAL HIP ARTHROPLASTY (THA) FOR DISPLACED COMMINUTED ACETABULAR FRACTURES. FROM JANUARY 1996 TO JUNE 2011,A CONSECUTIVE SERIES OF 40 PATIENTS WITH ACETABULAR FRACTURES WERE TREATED WITH ACUTE THA WITH OR WITHOUT ORIF .FOUR PATIENTS DIED WITHIN 90 DAYS OF THEIR SURGERY AS THE RESULT OF THEIR INJURIES OR ACUTE MEDICAL COMPLICATIONS. TWO PATIENTS WERE UNABLE TO BE LOCATED, AND 1 DECLINED TO PARTICIPATE. A TOTAL OF 33 PATIENTS (15 MALE 18 FEMALE) WITH A MEAN AGE OF 66 YEARS WERE INCLUDED IN THE STUDY. FOUR PATIENTS (12%) HAD DISPLACED FRACTURES OF THE ANTERIOR COLUMN, WHICH WAS TREATED BY THE SUPINE ILIOINGUINAL APPROACH WITH A PELVIC RECONSTRUCTION PLATE (SYNTHES, PAOLI, PA) ALONG THE PELVIC BRIM BEFORE BEING REPOSITIONED FOR THE POSTERIOR APPROACH. THE MEAN AVERAGE FOLLOW-UP WAS 5.6 YEARS (RANGE, 1¿14.3 YEARS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: A CASE OF A (B)(6) YEAR-OLD FEMALE TREATED BY SUPINE ILIOINGUINAL APPROACH HAD AN EARLY COMPLICATION OF PULMONARY EDEMA. A CASE OF A (B)(6) YEAR-OLD MALE TREATED BY SUPINE ILIOINGUINAL APPROACH HAD AN EARLY COMPLICATION OF URINARY TRACT INFECTION. A CASE OF AN (B)(6) YEAR OLD MALE TREATED BY SUPINE ILIOINGUINAL APPROACH HAD HETEROTROPIC OSSIFICATION I AT THE MOST RECENT FOLLOW-UP, 6 PATIENTS (18%) HAD DIED OF UNRELATED CAUSES AND FUNCTIONAL RESULTS COULD NOT BE OBTAINED. THESE IMPACTED PRODUCTS CAPTURE A CASE OF AN (B)(6) YEAR OLD MALE TREATED BY SUPINE ILIOINGUINAL APPROACH WHO HAD HETEROTOPIC OSSIFICATION I. MEDICAL HISTORY: MARGINAL IMPACTION OF THE ACETABULUM. THIS REPORT IS FOR AN UNKNOWN SYNTHES PELVIC RECONSTRUCTION PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570457 PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention