BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: LCP PROXIMAL TIBIA

    MDR report key: 17107085 · Received June 12, 2023

    Report

    Report Number
    8030965-2023-07376
    Event Type
    Injury
    Date Received
    June 12, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: A1, A2, A3, A4: THERE ARE MULTIPLE PATIENTS. ALL KNOWN INFORMATION IS PROVIDED IN THE LITERATURE ARTICLE. D1, D2, D3, D4, G4 - 510K: THIS REPORT IS FOR AN UNKNOWN LCP CONSTRUCT/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. D6: THERE ARE MULTIPLE UNKNOWN DATES OF IMPLANTATION BETWEEN JANUARY 1, 2010 AND DECEMBER 31, 2019. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: 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.

    Description of Event or Problem · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: MILANI, L, AND FERRARI, S. (2022), IMPORTANCE OF CT SCAN IN PREDICTING THE OUTCOMES OF TIBIAL PLATEAU FRACTURES: A RETROSPECTIVE STUDY OF 216 PATIENTS OVER 10 YEARS¿ TIME, INDIAN JOURNAL OF ORTHOPAEDICS, VOL. 56, PAGES 377-385 (ITALY) THE PRIMARY AIM OF THIS RETROSPECTIVE STUDY WAS TO ASSESS THE POSTOPERATIVE CLINICAL, FUNCTIONAL, AND RADIOGRAPHIC OUTCOMES OF PATIENTS WITH CLOSED TIBIAL PLATEAU FRACTURES (TPFS) SURGICALLY TREATED WITH PROXIMAL TIBIAL LOCKING COMPRESSION PLATE (LCP) SYSTEM WITH A FOCUS ON THE USE OF PREOPERATIVE CT SCAN. TWO HUNDRED AND SIXTEEN PATIENTS (121 FEMALES AND 95 MALES) WITH TPFS WHO UNDERWENT SURGICAL TREATMENT IN OUR DEPARTMENT BETWEEN JANUARY 2010 AND DECEMBER 2019 WERE ENROLLED IN THIS STUDY. IMPLANTS USED WERE LCP. POSTOPERATIVE FOLLOW-UP VISITS OF PATIENT SCREENED WERE PERFORMED AT 1, 3, 6 MONTHS AND 1 YEAR AFTER SURGERY. THE MEAN DURATION OF FOLLOW-UP WAS 45 MONTHS (6¿86 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED: AS REGARDS RADIOGRAPHIC OUTCOMES, WE FOUND THE X-RAY GROUP HAD WORSE RESULTS THAN THE CT GROUP IN THE RATE OF VARUS¿VALGUS ALIGNMENT AND STEP-OFF WORSENING. ACCORDING TO THE KELLGREEN¿LAWRENCE CLASSIFICATION, THE LEVEL OF OSTEOARTHRITIS WORSENED IN 43 PATIENTS OUT OF 121 IN THE X-RAY GROUP, BUT IN ONLY 23 OUT OF 95 IN THE CT GROUP. THIS REPORT IS FOR AN UNKNOWN SYNTHESE LOCKING COMPRESSION PLATE (LCP) SYSTEM. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS REPORT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427812 UNK - CONSTRUCTS: LCP PROXIMAL TIBIA PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention