BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES: 4.5MM VA LCP CONDYLAR PLATE

    MDR report key: 12526372 · Received September 24, 2021

    Report

    Report Number
    8030965-2021-07989
    Event Type
    Injury
    Date Received
    September 24, 2021
    Report Date
    August 26, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # : (B)(4). THIS REPORT IS FOR AN UNK - PLATES: 4.5MM VA LCP CONDYLAR PLATE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI 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 AS NO PRODUCT WAS RECEIVED. : THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. 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 · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: MITTAL A., POOLE W., CRONE D., (2021) INTERPROSTHETIC FEMORAL FRACTURES MANAGED WITH MODERN DISTAL FEMORAL LOCKING PLATES: 10-YEARS¿ EXPERIENCE AT A UK MAJOR TRAUMA CENTER, INJURY VOLUME 52, PAGES 1918¿1924 (UNITED KINGDOM). THIS RETROSPECTIVE STUDY AIMS TO EVALUATE OUTCOMES OF IFFS MANAGED WITH MODERN PRE-CONTOURED DISTAL FEMORAL LOCKING PLATES (DFLPS), IN A LARGER SAMPLE SIZE THAN PREVIOUSLY PUBLISHED. BETWEEN DECEMBER 2009 AND DECEMBER 2019, 49 CLOSED IFFS IN 48 PATIENTS WITH AN AVERAGE AGE OF 83 YEARS (RANGE 52-100 YEARS), THE MAJORITY WERE FEMALE (N = 39) WITH INTER-AND PERI-PROSTHETIC FEMORAL FRACTURES OCCURRING BETWEEN PREVIOUS TOTAL HIP ARTHROPLASTY (N = 38), HE HIPS ARTHROPLASTY (N = 3), DYNAMIC HIP SCREW (N = 6) OR CEPHALOMEDULLARY NAIL (N = 2) AND TOTAL KNEE ARTHROPLASTY TREATED OPERATIVELY WERE REVIEWED. ALL FRACTURES WERE MANAGED WITH MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS (MIPO) EMPLOYING MODERN BIOLOGICAL FIXATION TECHNIQUES AND STABILIZED WITH EITHER 4.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATING SYSTEM (SYNTHES, WEST CHESTER, PENNSYLVANIA) (N = 28) OR 4.5MM PERI- LOC DISTAL FEMUR LOCKING PLATE SYSTEM (SMITH & NEPHEW, ANDOVER, MASSACHUSETTS) (N = 21) PLATE. SCREWS WERE INSERTED EITHER BICORTICAL OR UNICORTICAL AS REQUIRED PROXIMALLY AND DISTALLY. SOME FRACTURES REQUIRED ADDITIONAL FIXATION WITH CABLES OR LOCKING ATTACHMENT PLATES AND THIS WAS RECORDED. THE FOLLOWING COMPLICATIONS WERE REPORTED: 5 DIED WITH ONLY A RADIOGRAPH WITHIN THE FIRST 2 MONTHS POSTOPERATIVELY, 8 DIED WITH NO RADIOGRAPH POSTOPERATIVELY. THESE 13 PATIENTS DIED PRIOR TO THE UNION. IN ALL, THERE WAS A HIGH MORTALITY RATE ASSOCIATED WITH THE POPULATION GROUP. (N = 20/49) OF PATIENTS DIED, (10/20) OF THOSE WITHIN 6 MONTHS OF THEIR OPERATION. DUE TO A LARGE NUMBER OF CO-MORBID ELDERLY IN THE STUDY POPULATION, A LARGE NUMBER DIED PRIOR TO RADIOGRAPHIC FOLLOW-UP. A CASE OF AN (B)(6) YEAR-OLD MALE, INITIALLY TREATED WITH 16-HOLE VA CONDYLAR: 6 SCREWS DISTALLY, 6 SCREWS PROXIMALLY, WORKING LENGTH 5H. HAD NON-UNION AND METALWORK FAILURE AT 3 MONTHS POST-FIXATION. THE PLATE BROKE AT THE LEVEL OF FRACTURE WITH MINIMAL APPEARANCE OF CALLUS. FIXATION TOO STIFF FOR FRACTURE PATTERN, SOME TRANSLATION ACCEPTED. THE PATIENT UNDERWENT REVISION FIXATION WITH 18-HOLE VA CONDYLAR: 3 SCREWS PROXIMALLY, 8 SCREWS DISTALLY, LONGER WORKING LENGTH ADOPTED (8 HOLES). ACHIEVED UNION AFTER 3 MONTHS WITH IMMEDIATE POSTOPERATIVE WEIGHT BEARING ALLOWED. A CASE OF A (B)(6) YEAR-OLD MALE, INITIALLY TREATED WITH 16-HOLE VA CONDYLAR: 9 SCREWS DISTALLY AROUND CEMENTED STEMMED REVISION TKR, 4 SCREWS PROXIMALLY AND 1 CABLE, WORKING LENGTH 5H. HAD NON-UNION AND METALWORK FAILURE AT 6 WEEKS AFTER THE INITIAL SURGERY. THE PLATE BROKE AT THE LEVEL OF THE FRACTURE WITH MINIMAL APPEARANCES OF CALLUS AT 6 WEEKS. FIXATION STIFF AND CABLE AFFECTED BIOLOGY. THE PATIENT UNDERWENT REVISION FIXATION WITH 16-HOLE VA CONDYLAR: 5 SCREWS PROXIMALLY, 6 DISTALLY LONGER WORKING LENGTH. CALLUS FORMED BUT THE PLATE BROKE PRIOR TO THE UNION. THE PATIENT UNDERWENT A SECOND REVISION WITH 16-HOLE PERILOC: 6 SCREWS PROXIMALLY, 8 DISTALLY STIFF CONSTRUCT FIXATION FOR UNIPLANAR NONUNION. ACHIEVED UNION (5 MONTHS POST 2ND REVISION). 6 PATIENTS HAD INTER-AND PERI-PROSTHETIC FEMORAL FRACTURES OCCURRING BETWEEN PREVIOUS DYNAMIC HIP SCREW SURGERY. 8 OF THE IFFS OCCURRED IN PATIENTS WITH PREVIOUS DHS. ALL PATIENTS WITH A DHS ABOVE THE FRACTURE HAD THE SIDE PLATE REMOVED, AND THE DFLP CONTOURED FOR THE TROCHANTERIC FLARE, AIMING FOR A SCREW TO BE IMPLANTED INTO THE FEMORAL NECK. THIS REPORT IS FOR AN UNKNOWN SYNTHES 4.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATING SYSTEM. THIS REPORT IS FOR (1) UNK - PLATES: 4.5MM VA LCP CONDYLAR PLATE. THIS REPORT IS 1 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421908 UNK - PLATES: 4.5MM VA LCP CONDYLAR PLATE PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention