BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: LOCKING: TRAUMA

    MDR report key: 18371749 · Received December 21, 2023

    Report

    Report Number
    8030965-2023-16001
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    October 17, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    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. H10 ADDITIONAL NARRATIVE: D1, D2, D3, D4, G4 ¿ 510K: THIS REPORT IS FOR AN UNKNOWN SCREW: LOCKING: TRAUMA/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI 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. 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: TSUNEARI, T., KUBO, T., YUYA, K., NAOKI, Y. KATSUSHI, T., (2022) 3D TEMPLATING AND PATIENT-SPECIFIC INSTRUMENTATION IN PRIMARY TOTAL KNEE ARTHROPLASTY WITH RETAINED INTERNAL FIXATION HARDWARE: TWO CASE REPORTS, TRAUMA CASE REPORTS, VOL. 42 (100716), PAGES 2352-6440 (JAPAN). THIS CASE REPORT PRESENTS A CASE OF A 75-YEAR-OLD - WOMAN WHO WAS ADMITTED TO THE KNEE SPORTS TRAUMATOLOGY DEPARTMENTAL CLINIC IN A HOSPITAL DUE TO COMPLAINTS OF CHRONIC PAIN AND KNEE INSTABILITY WHILE WALKING. RADIOGRAPHY REVEALED KELLGREN¿LAWRENCE (KL) GRADE 4 KOA AND A VARUS KNEE DEFORMITY OF 10.3¿. THE RANGE OF MOTION WAS - 20¿ DURING EXTENSION AND 110¿ DURING FLEXION. TEN YEARS BEFORE ADMISSION, SHE HAD UNDERGONE INTERNAL FIXATION WITH LCP DISTAL FEMUR PLATES (DEPUYSYNTHES, SOLOTHURN, SWITZERLAND) AS A TREATMENT FOR AN AO 33-A1 DISTAL FEMORAL FRACTURE. PREOPERATIVE PLANNING OF THE PROPHECY EVOLUTION MEDIAL PIVOT PATIENT-SPECIFIC INSTRUMENTED KNEE REPLACEMENT SYSTEMS (MICROPORT ORTHOPEDICS, INC., ARLINGTON, TN) REVEALED THAT AT LEAST THREE DISTAL LOCKING SCREWS NEEDED TO BE REMOVED DURING FEMORAL BONE RESECTION USING A FOUR-IN-ONE CUTTING GUIDE. THEREFORE, PSI-ASSISTED MECHANICALLY ALIGNED (MA)-CRUCIATE RETAINING (CR) TKA WAS PLANNED FOLLOWING PARTIAL SCREW REMOVAL FROM THE LCP. ANOTHER TWO DISTAL LOCKING SCREWS WERE REMOVED BECAUSE THEY HAD BECOME VISIBLE AND MIGHT INTRUDE ON THE FEMORAL COMPONENT. THE DISTAL FEMORAL AND PROXIMAL TIBIAL CUT LINES WERE THEN DEFINED ACCORDING TO PSI PIN LOCATIONS TO GET A RECTANGULAR EXTENSION GAP. THE TRANSEPICONDYLAR AXIS (TEA) OF THE FEMUR WAS 2.0¿ EXTERNAL FROM THE POSTERIOR CONDYLES. FIRST, AN ADEQUATE FLEXION GAP WAS OBTAINED BY SETTING THE OSTEOTOMY LINE OF THE POSTERIOR CONDYLES PARALLEL TO THE TEA ACCORDING TO THE SIZE SUGGESTION OF THE FEMORAL COMPONENT FROM PSI. THEN, THE 12-MM CR-FIXED BEARING WAS INSERTED AND THE POSTOPERATIVE ROM UNDER ANESTHESIA AFTER INCISION CLOSURE WAS MEASURED TO BE 0¿ DURING EXTENSION AND 125¿ DURING FLEXION. DURING A 2-YEAR FOLLOW-UP PERIOD, NO SUPERFICIAL OR DEEP INFECTION WAS OBSERVED, AND HER VISUAL ANALOG SCALE (VAS; BEST: 0, WORST: 100) SCORE AT THE TIME OF WALKING ON EVEN GROUND HAD IMPROVED FROM 71 TO 0, AND HER OXFORD KNEE SCORE (OKS; BEST: 0, WORST: 48) HAD IMPROVED FROM 24 TO 2 AT THE TIME OF THE LATEST FOLLOW-UP. NO RADIOLOGICAL SIGNS OF SUSPECTED COMPONENT LOOSENING WERE OBSERVED. BESIDES, THE PATIENT CAN NOW WALK WITHOUT USING CRUTCHES. THIS REPORT IS FOR AN UNK - SCREW: LOCKING: TRAUMA. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2051871 UNK - SCREWS: LOCKING: TRAUMA SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention