BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: DHS/DCS

    MDR report key: 11672007 · Received April 15, 2021

    Report

    Report Number
    8030965-2021-02948
    Event Type
    Injury
    Date Received
    April 15, 2021
    Report Date
    March 19, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN DHS/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. 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 · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: MAHESHWARI, R., PEMMARAJU, K., SLOAN, R., AND HAMLET, M. (2004), PSEUDOANEURYSM OF PROFUNDA FEMORIS ARTERY FOLLOWING INTERTROCHANTERIC FRACTURE OF THE HIP, EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY, VOL.14, PAGES 192¿194 ((B)(6)) THIS STUDY PRESENTS A CASE REPORT OF A 78-YEAR-OLD MALE PATIENT WHO SUSTAINED A DISPLACED, UNSTABLE, CLOSED FOUR-PART INTERTROCHANTERIC FRACTURE OF THE LEFT HIP ALONG WITH IPSILATERAL COLLES FRACTURE FOLLOWING A FALL. HIS COLLES FRACTURE WAS REDUCED IN A&E UNDER INTRAVENOUS MIDAZOLAM, AND A BELOW-ELBOW CAST WAS GIVEN. THE PATIENT WAS OPERATED ON THE FOLLOWING DAY FOR HIS HIP FRACTURE, AND AFTER CLOSED REDUCTION ON THE FRACTURE TABLE; THE FRACTURE WAS FIXED INTERNALLY WITH AN AO DHS. TWELVE WEEKS POST-OPERATIVELY, HE PRESENTED WITH A 10X20 CM PAINLESS FIRM SWELLING IN THE LEFT GROIN DISTAL TO INGUINAL LIGAMENT RADIOLOGICAL EXAMINATION REVEALED COLLAPSE AT THE FRACTURE SITE WITH IMPLANTS IN SATISFACTORY POSITION, BUT THE LESSER TROCHANTERIC FRAGMENT REMAINED WIDELY SEPARATED FROM THE MEDIAL SIDE OF THE FEMORAL NECK. DUPLEX ULTRASOUND OF THE FEMORAL VESSELS DEMONSTRATED 7 CM SWELLING POSTERIOR TO THE COMMON FEMORAL AND PROFUNDA FEMORIS ARTERY. FIVE DAYS AFTER THE OPERATION, HIS GROIN SWELLING INCREASED IN SIZE. CONTRAST ENHANCED CT SCAN REVEALED PSEUDOANEURYSM IN CONTINUITY WITH PROFUNDA FEMORIS ARTERY AND ITS BRANCHES, UNDER LOCAL ANESTHESIA, LEFT ILIOFEMORAL ARTERIOGRAPHY WAS DONE, WHICH REVEALED FALSE ANEURYSM OF THE PROFUNDA FEMORIS ARTERY. POST-EMBOLIZATION DUPLEX ULTRASOUND SHOWED ANEURYSMAL SAC CONFIRMED TO BE THROMBOSED WITH PATENT PROFUNDA FEMORIS AND SUPERFICIAL FEMORAL ARTERY, BUT THERE WAS THROMBUS IN THE MID-FEMORAL VEIN AND POPLITEAL VEIN WITH SOME RE-CANALIZATION. IN VIEW OF THIS DEEP VEIN THROMBOSIS, AN IVC FILTER WAS DEPLOYED ON THE THIRD POST-OPERATIVE DAY, AND THE PATIENT WAS COMMENCED ON WARFARIN 2 WEEKS POST-EMBOLIZATION. AT THE 4-MONTH SURGICAL AND ORTHOPEDIC REVIEW, THE PATIENT WAS WELL WITH NO THIGH TENDERNESS AND GOOD HIP MOBILITY. THIS REPORT IS FOR AN UNKNOWN SYNTHES DHS A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568458 UNK - SCREWS: DHS/DCS APPLIANCE,FIXATION,NAIL KTT SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention