BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PLATE/SCREWS

    MDR report key: 10453379 · Received August 26, 2020

    Report

    Report Number
    2939274-2020-03799
    Event Type
    Injury
    Date Received
    August 26, 2020
    Report Date
    July 31, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: PLATE/ SCREWS/ UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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. (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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ZITSCH, B.P. ET AL. (2020), PATIENT-REPORTED OUTCOMES FOR LARGE BIPOLAR OSTEOCHONDRAL ALLOGRAFT TRANSPLANTATION IN COMBINATION WITH REALIGNMENT OSTEOTOMIES FOR THE KNEE, THE JOURNAL OF KNEE SURGERY, VOL XX, PAGES 1-7, (USA). THE PURPOSE OF THIS STUDY WAS TO EVALUATE CLINICAL AND PATIENT REPORTED OUTCOMES FOR A COHORT OF PATIENTS WHO UNDERWENT SURGICAL RESTORATION OF THE KNEE BY OSTEOCHONDRAL ALLOGRAFT (OCA) TRANSPLANTATION, WITH EITHER STAGED OR CONCURRENT DISTAL FEMORAL OSTEOTOMY (DFO) OR HIGH TIBIAL OSTEOTOMY (HTO). THE OVERALL GOAL IS TO DEMONSTRATE THAT COMBINED OCA TRANSPLANTATION WITH OSTEOTOMY CAN YIELD CLINICALLY MEANINGFUL IMPROVEMENTS IN PATIENT REPORTED OUTCOMES. MAY 2016 TO MARCH 2018, 23 PATIENTS (15 MALES AND 8 FEMALES) WHO UNDERWENT PRIMARY OCA TRANSPLANTATION USING THE MISSOURI OSTEOCHONDRAL PRESERVATION SYSTEM (MOPS)¿PRESERVED OCA AND MENISCAL ALLOGRAFT ALONG WITH CONCURRENT OR STAGED DFO OR HTO SURGERIES WERE ANALYZED. 13 PATIENTS RECEIVED HTO, 5 OF WHICH HAD A CONCURRENT PROCEDURE. 10 PATIENTS RECEIVED DFO, FIVE OF WHICH WERE CONCURRENT. IMPLANTS USED FOR OSTEOTOMIES WERE LOCKING PLATES (TOMOFIX; DEPUY SYNTHES, PAOLI, PA) WITH A COMBINATION OF LOCKING AND CORTICAL SCREWS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 4 PATIENTS UNDERWENT REVISIONS. THE FOUR PATIENTS UNDERGOING REVISION MET FUNCTIONAL CRITERIA FOR SUCCESS AT FINAL FOLLOW-UP, RESULTING IN A 2-YEAR SURVIVAL RATE OF 87.4%. 3 PATIENTS FAILED AND WERE CONVERTED TO TKA DURING THE STUDY PERIOD. 1 PATIENTS EXPERIENCED A MAJOR COMPLICATION (SEPTIC KNEE OR OSTEOMYELITIS) REQUIRING REOPERATION. THIS REPORT IS FOR AN UNKNOWN SYNTHES LOCKING PLATES (TOMOFIX; DEPUY SYNTHES, PAOLI, PA) WITH A COMBINATION OF LOCKING AND CORTICAL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920888 UNK - CONSTRUCTS: PLATE/SCREWS PLATE,FIXATION,BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention