BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: AFN

    MDR report key: 15484958 · Received September 26, 2022

    Report

    Report Number
    8030965-2022-07332
    Event Type
    Injury
    Date Received
    September 26, 2022
    Date of Event
    June 10, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. ADDITIONAL NARRATIVE: THIS REPORT IS FOR AN UNKNOWN CONSTRUCT: AFN/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. 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: KUBES K., ET AL (2021) MANAGEMENT OF TWENTY CENTIMETER SEGMENTAL BONE DEFECT OF FEMORAL SHAFT SECONDARY TO INFECTED NON-UNION OF FRACTURE USING MASQUELET TECHNIQUE: A CASE REPORT, INTERNATIONAL JOURNAL OF SURGERY CASE REPORTS VOLUME 84, PAGES 1-9 (USA) THIS STUDY PRESENTS A CASE REPORT OF A PATIENT TO DESCRIBE A SUCCESSFUL TREATMENT OF A 20 CM FEMORAL SHAFT BONE DEFECT SECONDARY TO TRAUMA AND SUBSEQUENT INFECTION. A 28-YEAR-OLD MALE WHO PRESENTED TO OUR CLINIC FOR EVALUATION AND TREATMENT FOR A SEGMENTAL BONE DEFECT SECONDARY TO A RIGHT FEMUR FRACTURE WITH NON-UNION AFTER INFECTION. HE HAD SUSTAINED AN ISOLATED, CLOSED, MID-SHAFT RIGHT FEMUR FRACTURE IN A MOTOR VEHICLE COLLISION IN HIS HOME COUNTRY OF UGANDA APPROXIMATELY TWO YEARS PRIOR TO PRESENTATION AT OUR CLINIC AND WAS TREATED AT THE TIME OF INJURY WITH AN INTRAMEDULLARY (IM) FEMORAL NAIL. APPROXIMATELY THREE MONTHS AFTER HIS INITIAL SURGERY, HE WAS NOTED TO HAVE SIGNS AND SYMPTOMS OF AN INFECTED NON-UNION, AND UNDERWENT IRRIGATION & DEBRIDEMENT (I&D) IN UGANDA. THE PATIENT SUBSEQUENTLY IMMIGRATED TO THE UNITED STATES AND PRESENTED AT ANOTHER INSTITUTION WITH A DRAINING SINUS TRACT AT HIS FRACTURE SITE. HE WAS PLACED ON MULTIPLE ANTIBIOTICS AND UNDERWENT AN ADDITIONAL I&D. HIS ORIGINAL IM NAIL WAS LEFT IN PLACE AT THAT TIME. THE PATIENT'S INTRAOPERATIVE CULTURES GREW A MULTI-DRUG RESISTANT SPECIES OF ENTEROCOCCUS AND A METHICILLIN-SENSITIVE STAPHYLOCOCCUS. OVER THE NEXT TWELVE MONTHS, THE PATIENT WAS TREATED WITH MULTIPLE ANTIBIOTICS AND UNDERWENT FIVE ADDITIONAL I&DS, THE LATTER FOUR INCLUDING ADDITIONAL BONE EXCISION AND ATTEMPTS AT INDUCED MEMBRANE TECHNIQUE WITH INTRAMEDULLARY NAIL EXCHANGES AND ANTIBIOTIC CEMENT SPACER PLACEMENT. PRIOR TO HIS FINAL SURGERY, SKIN WOUND CULTURES GREW A MULTI-DRUG RESISTANT STAPHYLOCOCCUS EPIDERMIDIS SPECIES. AT THE TIME OF PRESENTATION TO OUR CLINIC, THE PATIENT WAS THREE MONTHS POST-OPERATIVE FROM HIS LAST ANTIBIOTIC NAIL EXCHANGE, WITH AN EIGHT MM ANTIBIOTIC COATED INTRAMEDULLARY NAIL (SMITH AND NEPHEW; LONDON, UK). IN PLACE, AND WAS NO LONGER TAKING ANTIBIOTICS. RADIOGRAPHS SHOWED A 20 CM BONE DEFECT AT THE MID-SHAFT OF THE RIGHT FEMUR, AS WELL AS A 3 CM LEG LENGTH DISCREPANCY. THE PATIENT ALSO UNDERWENT A THOROUGH MEDICAL, ENDOCRINE AND METABOLIC WORKUP TO ENSURE NO OTHER CONDITIONS CONTRIBUTED TO THE NON-UNION. HE WAS OPTIMIZED FOR SURGICAL TREATMENT OF HIS BONE DEFECT. GIVEN THE SIGNIFICANT SIZE OF HIS DEFECT, IT WAS OPTED TO TREAT HIM UTILIZING THE MASQUELET TECHNIQUE.THE FIRST STAGE OF HIS MASQUELET OPERATION WAS THEN PERFORMED. THE REAMER IRRIGATOR ASPIRATOR (RIA; DEPUYSYNTHES; JOHNSON & JOHNSON CO. INC., NJ) WAS USED TO DEBRIDE THE FEMORAL CANAL USING 3 L OF NORMAL SALINE (NS) WITH BACITRACIN, FOLLOWED BY 3 L OF NS. A NEW LATERAL ENTRY ANTEGRADE FEMORAL INTRAMEDULLARY NAIL (12X440MM; DEPUY SYNTHES, RAYNHAM, MASSACHUSETTS) WITH ONE PROXIMAL AND THREE DISTAL INTERLOCKING SCREWS WAS PLACED. NEXT, A TEMPORARY PMMA (PALACOS; ZIMMER, WARSAW, IN) ANTIBIOTIC CEMENT SPACER WAS MADE BY MIXING THREE BAGS (40 G PER BAG) OF CEMENT, 7 G VANCOMYCIN, AND 5 G OF MEROPENEM. POST-OPERATIVELY, THE PATIENT REMAINED ON INTRAVENOUS ANTIBIOTICS UNTIL POST-OPERATIVE DAY 4, WHEN INTRAOPERATIVE CULTURES REMAINED WITHOUT GROWTH. RADIOGRAPHS WERE OBTAINED PRIOR TO HOSPITAL DISCHARGE, DEMONSTRATING THE CEMENT SPACER'S SATISFACTORY POSITION AND THE INTRAMEDULLARY NAIL. FIVE WEEKS AFTER THE FIRST STAGE, THERE WAS STILL NO CLINICAL OR LABORATORY EVIDENCE OF INFECTION, AND THE SECOND STAGE OF HIS MASQUELET OPERATION WAS PERFORMED. NEW CULTURES WERE OBTAINED, AND THE ANTIBIOTIC CEMENT SPACER WAS REMOVED WHILE THE PRIOR INTRAMEDULLARY NAIL WAS LEFT IN PLACE . NEXT, 75 CC OF AUTOLOGOUS BONE GRAFT WAS TAKEN FROM THE CONTRALATERAL FEMUR WITH THE RIA, AND 60 CC OF BONE MARROW ASPIRATE WAS TAKEN FROM THE CONTRALATERAL ILIAC CREST. THIS WAS COMBINED WITH 45 CC OF ALLOGRAFT CANCELLOUS CHIPS AND 50 CC OF VIVIGEN CELLULAR BONE MATRIX (DEPUYSYNTHES; JOHNSON & JOHNSON CO. INC., NJ).POST-OPERATIVELY, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND 48 H OF PROPHYLACTIC ANTIBIOTICS. HE WAS MADE NON-WEIGHT BEARING TO HIS AFFECTED LOWER EXTREMITY, AND A BONE STIMULATOR WAS STARTED IMMEDIATELY. THE INTRAOPERATIVE CULTURES FROM HIS SECOND STAGE OPERATION REMAINED WITHOUT GROWTH. TWO WEEKS AFTER HIS SECOND STAGE MASQUELET OPERATION, HE BEGUN TO WEIGHT-BEAR FULLY WITHOUT CRUTCHES. AT ONE YEAR FOLLOW-UP, THE PATIENT DEMONSTRATED CLINICAL AND RADIOGRAPHIC UNION OF HIS BONE DEFECT WITH A RESIDUAL 2 CM LEG LENGTH DISCREPANCY. AT HIS TWO-YEAR FOLLOW-UP, RADIOGRAPHS CONTINUED TO HAVE A SATISFACTORY APPEARANCE, AND THE PATIENT ENDORSED OVERALL SIGNIFICANT IMPROVEMENT IN QUALITY OF LIFE AND FUNCTIONALITY. HE WAS NOTED TO HAVE CONTINUED RIGHT PATELLOFEMORAL KNEE PAIN AND REQUIRED A SHOE LIFT FOR HIS LEG LENGTH DISCREPANCY, WHICH HE DID NOT ROUTINELY WEAR. PAIN MANAGEMENT WAS CONSULTED. HE UNDERWENT AN INFERIOR-MEDIAL GENICULAR NERVE BLOCK AND NERVE BLOCKS OF THE SCIATIC AND FEMORAL NERVES' SENSORY BRANCHES, WHICH DID NOT HELP. TWO YEARS AFTER THE SECOND STAGE OF HIS OPERATION, HIS PAIN WAS WELL MANAGED WITH 400 MG OF GABAPENTIN 3 TIMES DAILY AND TWO TABS OF 5/325 MG OXYCODONE-ACETAMINOPHEN PER DAY. ULTIMATELY, HIS GOAL WAS TO STOP NARCOTICS COMPLETELY. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR AN UNK - CONSTRUCT: AFN. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768185 UNK - CONSTRUCTS: AFN APPLIANCE, FIXATION, NAIL KTT SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male Required Intervention