BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - NAIL HEAD ELEMENTS: HELICAL BLADE

    MDR report key: 16141393 · Received January 11, 2023

    Report

    Report Number
    8030965-2023-00422
    Event Type
    Injury
    Date Received
    January 11, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. THIS REPORT IS FOR AN UNKNOWN NAIL HEAD ELEMENTS: HELICAL BLADE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER NAME AND ADDRESS: (B)(6). 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 CHINA AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SHI, T. ET AL. (2022), CONVERSION HIP ARTHROPLASTY USING STANDARD AND LONG STEMS AFTER FAILED INTERNAL FIXATION OF INTERTROCHANTERIC FRACTURES, ORTHOPAEDIC SURGERY, VOL. 9999, PAGES 1-9 (CHINA). THE PURPOSE OF THIS MULTICENTER RETROSPECTIVE STUDY WAS: (I) TO EVALUATE THE RESULTS, TECHNICAL PROBLEMS, AND COMPLICATIONS OF CONVERSION HIP ARTHROPLASTY (CHA) FOLLOWING FAILED INTERNAL FIXATION OF INTERTROCHANTERIC FRACTURES (FIF-ITF) PATIENTS IN MULTICENTERS; AND (II) TO COMPARE THE CLINICAL EFFICIENCY OF STANDARD AND LONG STEMS IN THIS OPERATION. THIS RETROSPECTIVE, MULTI-CENTER STUDY ENROLLED 31 TOTAL HIP ARTHROPLASTY (THA) AND 23 HEMIARTHROPLASTIES (HA) CASES (30 WOMEN, 24 MEN; MEAN AGE 76 YEARS) AFTER FIF-ITF BETWEEN 2012 AND 2019, DIVIDED INTO TWO GROUPS: STANDARD STEM GROUP (N = 20) AND LONG STEM GROUP (N = 34). THE INITIAL INTERNAL FIXATION INCLUDES 38 CASES OF PROXIMAL FEMORAL NAIL ANTI-ROTATION (PFNA), EIGHT CASES OF THE DYNAMIC HIP SCREW (DHS), AND EIGHT CASES OF LOCKING PROXIMAL FEMORAL PLATE (LPFP). THE ARTICLE DOES NOT PROVIDE SUFFICIENT INFORMATION TO IDENTIFY WHICH SYNTHES DEVICE (PFNA OR DHS) IS ASSOCIATED WITH THE ADVERSE EVENT. (N=38) FAILURE OF FIXATION (CUT OUT). (N=7) NONUNION. (N=9) AVASCULAR NECROSIS OR POSTTRAUMATIC OSTEOARTHRITIS. A 70-YEAR-OLD MALE PATIENT WITH A RIGHT COMMINUTED INTERTROCHANTERIC FRACTURE WAS TREATED WITH PFNA AND RECEIVED THA AFTER FAILED INTERNAL FIXATION. THIS REPORT IS FOR AN UNKNOWN SYNTHES DHS AND PFNA. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178612 UNK - NAIL HEAD ELEMENTS: HELICAL BLADE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention