BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: LCP DISTAL FEMUR PLATE/SCREWS

    MDR report key: 17483974 · Received August 8, 2023

    Report

    Report Number
    8030965-2023-10017
    Event Type
    Injury
    Date Received
    August 8, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, 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: D1, D2, D3, D4, G4-510K: THIS REPORT IS FOR AN UNKNOWN SYNTHES 3.5 MM LCP PLATE/SCREWS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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: CAINES A., ADAMCZYK A., MAHAFFEY R., AND PICKELL M. (2023), OPEN REDUCTION INTERNAL FIXATION VERSUS DISTAL FEMORAL REPLACEMENT (DFR) FOR TREATMENT OF OTA/AO33C FRACTURES IN THE ELDERLY: A REVIEW OF FUNCTIONAL OUTCOMES AND COST ANALYSIS, JOURNAL OF ORTHOPAEDIC TRAUMA, VOL. 37 (1), PAGES 14-18 (CANADA). THE AIM OF THIS RETROSPECTIVE, CONSECUTIVE, MULTISURGEON, COHORT STUDY IS TO DETERMINE THE ECONOMIC COST ASSOCIATED WITH THE TREATMENT OF OTA/AO 33C FRACTURES IN PATIENTS OLDER THAN 65 YEARS OF AGE USING OPEN REDUCTION INTERNAL FIXATION (ORIF) OR DFR AND TO ASSESS THE PERIOPERATIVE OUTCOMES OF ELDERLY PATIENTS TREATED SURGICALLY FOLLOWING OTA/AO 33C FRACTURES. BETWEEN 2009 AND 2019, A TOTAL OF 39 PATIENTS WERE INCLUDED IN THE STUDY. AMONG THESE, 12 PATIENTS (ALL WERE FEMALES; MEAN AGE WAS 83.0 (RANGE, 65¿101) YEARS) UNDERWENT DISTAL FEMORAL REPLACEMENT (DFR) WHEREAS 27 PATIENTS (22 WERE FEMALE; MEAN AGE WAS 80.1 (RANGE, 66¿98) YEARS) UNDERWENT ORIF AS THE INDEX PROCEDURE. FRACTURE FIXATION WAS PERFORMED USING A SYNTHES LCP LOCKING DISTAL FEMUR PLATE OR BICOLUMNAR PLATING WITH THE ADDITION OF THE SYNTHES 3.5 MM LCP PLATING SYSTEM (SYNTHES, WEST CHESTER, PA). PATIENTS WHO UNDERWENT DFR WERE TREATED WITH A COMPETITOR DEVICE. TIME FROM INDEX PROCEDURE TO TIME OF FOLLOW-UP WAS SIGNIFICANTLY DIFFERENT, WITH AN AVERAGE TIME SINCE SURGERY OF 2.20 (±1.18) YEARS FOR THE DFR GROUP AND 6.54 (±2.97) YEARS FOR THE ORIF GROUP. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: ORIF GROUP: 1 CASE OF PERIOPERATIVE MORTALITY DUE TO POSTOPERATIVE PNEUMONIA. 3 CASES OF 1-YEAR MORTALITY. 4 PATIENTS HAD NONUNION AND UNDERWENT REOPERATION BY REVISION ORIF (N=1) AND REVISIONS TO DFR (N=3). 1 PATIENT HAD DEEP INFECTION REQUIRING REOPERATION BY IRRIGATION AND DEBRIDEMENT. THIS REPORT IS FOR AN UNKNOWN SYNTHES 3.5 MM LCP PLATE/SCREWS. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1697906 UNK - CONSTRUCTS: LCP DISTAL FEMUR PLATE/SCREWS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention