BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: LCP DISTAL FIBULA PLATE/SCREWS

    MDR report key: 16077567 · Received December 30, 2022

    Report

    Report Number
    8030965-2022-11693
    Event Type
    Injury
    Date Received
    December 30, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: LCP DISTAL FIBULA PLATE/SCREWS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DEVICE AVAILABLE FOR EVALUATION: 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. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: USUI D., ET AL (2021) CORRECTIVE SURGERY FOR A FOREARM DEFORMITY IN A MIDDLE-AGED PATIENT WITH MULTIPLE HEREDITARY EXOSTOSES A CASE REPORT, JBJS CASE CONNECT VOLUME 11, PAGES 1-6 (JAPAN). THIS STUDY PRESENTS A CASE REPORT OF A SUCCESSFUL CASE OF CORRECTIVE SURGERY OF FOREARM DEFORMITY IN A MIDDLE-AGED PATIENT WITH MULTIPLE HEREDITARY EXOSTOSES (MHE). A 48-YEAR-OLD, RIGHT-HAND-DOMINANT MAN DEVELOPED A DEFORMITY OF THE LEFT FOREARM BECAUSE OF MHE FOR WHICH HE WAS FIRST DIAGNOSED AT AN EARLY AGE. HE WANTED TO UNDERGO CORRECTIVE SURGERY MAINLY FOR ESTHETIC REASONS. RADIOGRAPHS SHOWED EXOSTOSES ON THE DISTAL END OF THE ULNA, SHORTENING OF THE ULNA, BOWING OF THE RADIUS, AND ULNAR DEVIATION OF THE DISTAL ASPECT OF THE RADIUS AND WRIST. THE RADIAL ARTICULAR ANGLE (RAA), ULNAR VARIANCE (UV), RADIAL BOWING (RB), AND CARPAL SLIP (CS) WERE 57.9_, 213.7 MM, 15.7%, AND 46.3%, RESPECTIVELY. FOREARM CORRECTIVE SURGERY, INCLUDING CLOSING WEDGE OSTEOTOMY OF THE RADIUS AND ACUTE LENGTHENING OF THE ULNA, WAS PLANNED. THE RADIUS WAS STABILIZED WITH A 3.5-MM LOCKING COMPRESSION PLATE (LCP) (DEPUY SYNTHES). BECAUSE THE DISTAL ULNA HAD A COMPLICATED, UNEVEN MORPHOLOGY BECAUSE OF EXOSTOSIS, A STRAIGHT PLATE DID NOT FIT WELL; THEREFORE, WE STABILIZED THE ULNA WITH AN LCP DISTAL FIBULA POSTEROLATERAL PLATE (DEPUY SYNTHES) THAT FITS EFFECTIVELY. THE PATIENT STARTED PHYSICAL THERAPY 1 WEEK AFTER THE OPERATION. RADIOGRAPHIC UNION OF THE RADIUS AND ULNA WAS ACHIEVED AT 3 AND 8 MONTHS, RESPECTIVELY. HEREAFTER, ON THE 13TH MONTH POSTOPERATIVELY, THE PLATES AND SCREWS WERE RETRIEVED BECAUSE OF PAINFUL IRRITATION TO THE SKIN AND EXTENSOR MUSCLES BY THE IMPLANTS. AT THE FINAL FOLLOW-UP (14 MONTHS AFTER THE OPERATION), ACCEPTABLE ROM OF THE WRIST AND FOREARM WAS MAINTAINED, WITH 60_ EXTENSION, 40_ FLEXION, 70_ SUPINATION, AND 65_ PRONATION (FIGS. 5-A, 5-B, AND 5-C). THE FUNCTIONS OF HIS LEFT WRIST WERE MAINTAINED WITH A SCORE OF 9 IN THE HAND20 AND WITH LEFT GRIP STRENGTH OF 40.0 KG (100% OF THE UNAFFECTED SIDE). RADIOGRAPHS SHOWED 38.7_ RAA, 210.1-MM UV, 11.4% RB, AND 23.9% CS . MOREOVER, HE WAS PAIN-FREE. THE PATIENT WAS VERY SATISFIED WITH THE RESULT OF THE SURGERY. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT INVOLVES ONE UNK - CONSTRUCTS: LCP DISTAL FIBULA PLATE/SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2424282 UNK - CONSTRUCTS: LCP DISTAL FIBULA PLATE/SCREWS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Required Intervention UNK - CONSTRUCTS: 3.5 MM LCP PLATE/SCREWS.