BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: LCP DISTAL FEMUR PLATE/SCREWS

    MDR report key: 14416986 · Received May 17, 2022

    Report

    Report Number
    8030965-2022-03234
    Event Type
    Injury
    Date Received
    May 17, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FOR AN UNKNOWN LCP® DISTAL FEMUR PLATE/SCREWS CONSTRUCTS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K 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. 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: PAULSSON, M. ET AL. (2021), IMMEDIATE FULL WEIGHT-BEARING VERSUS PARTIAL WEIGHT-BEARING AFTER PLATE FIXATION OF DISTAL FEMUR FRACTURES IN ELDERLY PATIENTS. A RANDOMIZED CONTROLLED TRIAL, GERIATRIC ORTHOPAEDIC SURGERY & REHABILITATION, VOLUME 12: 1¿14 (SWEDEN). THE PURPOSE OF THIS STUDY WAS TO COMPARE THE FUNCTIONAL OUTCOME BETWEEN IMMEDIATE FULL WEIGHT-BEARING (FWB) AS TOLERATED AND PARTIAL WEIGHT-BEARING (PWB) DURING THE FIRST 8 WEEKS FOLLOWING PLATE FIXATION OF DISTAL FEMUR FRACTURES IN ELDERLY PATIENTS. BETWEEN JANUARY 2013 AND JUNE 2016, 32 PATIENTS WERE ENROLLED IN THIS STUDY. ELEVEN PATIENTS WERE RANDOMIZED TO FWB AND 21 PATIENTS TO PWB, IMPLANT USED WAS A STAINLESS-STEEL LCP® DISTAL FEMUR PLATE (SYNTHES, OBERDORF, SWITZERLAND)PATIENTS WERE FOLLOWED UP AT 8, 16, AND 52 WEEKS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: FWB GROUP: 1 PATIENT DIED AFTER 21 DAYS AFTER SURGERY AND IT WAS NOT DIRECTLY RELATED TO THE FEMUR FRACTURE OR ITS TREATMENT. 64% HAD PERI-IMPLANT FRACTURES. 1 PATIENT HAD DELAYED UNION DUE TO UNDETECTED ATYPICAL FRACTURE. IT WAS TREATED WITH NON-OPERATIVE TREATMENT INITIALLY BUT ULTIMATELY ADDITION OF LAG SCREWS. THERE WAS UNION. 1 PATIENT HAD SCREW TIP PROTRUDING THROUGH THE MEDIAL CORTEX OF THE FEMUR CONDYLE. IT WAS EXCHANGED TO SHORTER SCREWS. PAIN AND DISCOMFORT SUBSIDED. PWB GROUP: 3 PATIENTS DIED. 1 PATIENT DIED OF PULMONARY EMBOLISM WHILE STILL IN HOSPITAL, THE OTHER DEATHS OCCURRED AT 182, AND 364 DAYS AFTER SURGERY, NONE OF THEM WERE DIRECTLY RELATED TO THE FEMUR FRACTURE OR ITS TREATMENT. 74% HAD PERI-IMPLANT FRACTURES. 1 PATIENT HAD PROXIMAL SCREW BREAKAGE ADJACENT TO THR. IT WAS REVISED WITH PROXIMAL FIXATION WITH LATERAL ATTACHMENT PLATE. THERE WAS UNION. 1 PATIENT HAD DEEP INFECTION. IT WAS TREATED WITH DEBRIDEMENT ANTIBIOTICS IMPLANT RETENTION. 1 PATIENT HAD INDEPENDENT NEW FRACTURE OF THE LATERAL FEMUR CONDYLE, 1 WEEK POSTOPERATIVELY. THE SCREW WAS REMOVED DISTALLY. THERE WAS UNITED DISTAL FEMUR FRACTURE, POOR KNEE FUNCTION. 1 PATIENT HAD SCREW TIP PROTRUDING THROUGH THE MEDIAL CORTEX OF THE FEMUR CONDYLE. IT WAS EXCHANGED TO SHORTER SCREWS. PAIN AND DISCOMFORT SUBSIDED. THIS REPORT IS FOR AN UNKNOWN SYNTHES LCP® DISTAL FEMUR PLATE/SCREWS CONSTRUCTS. THIS REPORT CAPTURES THE REPORTED EVENTS OF PERI-IMPLANT FRACTURES, DELAYED UNION DUE TO UNDETECTED ATYPICAL FRACTURE AND DEEP INFECTION. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899323 UNK - CONSTRUCTS: LCP DISTAL FEMUR PLATE/SCREWS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention