BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - NAIL HEAD ELEMENTS

    MDR report key: 24022412 · Received January 9, 2026

    Report

    Report Number
    8030965-2026-00308
    Event Type
    Injury
    Date Received
    January 9, 2026
    Date of Event
    October 12, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. H11 ADDITIONAL NARRATIVE: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. INVESTIGATION SUMMARY ==> PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. 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 COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LI J, ZHANG C, LIN L, ZHANG N, HUANG J, HUANG Z, LIN H, WEI H, DING H, LIN S, ZHANG W, FANG X, HUANG J. EFFECTS AND COMPLICATIONS OF HIP ARTHROPLASTY AFTER FAILURE OF INTERNAL FIXATION IN STABLE AND UNSTABLE INTERTROCHANTERIC FEMORAL FRACTURES. ORTHOP SURG. 2025 NOV;17(11):3262-3271. DOI: 10.1111/OS.70184. EPUB 2025 OCT 12. PMID: 41077565; PMCID: PMC12580236. OBJECTIVE/METHODS/STUDY DATA: THIS MULTICENTER STUDY AIMS TO RETROSPECTIVELY ANALYZE THE DATA OF PATIENTS WHO UNDERWENT JOINT ARTHROPLASTY FOLLOWING THE FAILURE OF INTERTROCHANTERIC FRACTURES. THIS STUDY COMPARED THE CLINICAL OUTCOMES, RADIOLOGICAL RESULTS, AND INCIDENCE OF COMPLICATIONS ASSOCIATED WITH HIP ARTHROPLASTY IN PATIENTS WITH AT LEAST 3 YEARS OF FOLLOW-UP AFTER FIXATION FAILURE IN BOTH STABLE AND UNSTABLE FRACTURES. BETWEEN DECEMBER 2012 AND DECEMBER 2020, A TOTAL OF 103 PATIENTS (43 MALE AND 60 FEMALE) WHO UNDERWENT HIP ARTHROPLASTY DUE TO FAILED INTERNAL FIXATION OF INTERTROCHANTERIC FEMORAL FRACTURES WERE INCLUDED IN THE STUDY. ACCORDING TO THE AO/OTA CLASSIFICATION, THERE WERE 47 PATIENTS IN THE STABLE GROUP AND 56 IN THE UNSTABLE GROUP, WITH AVERAGE AGES OF 73.71 ± 12.79 YEARS AND 76.88 ± 10.13 YEARS, RESPECTIVELY. 48 CASES OCCURRED ON THE LEFT SIDE, AND 55 OCCURRED ON THE RIGHT SIDE. INTERNAL FIXATION USED TO TREAT THE INTERTROCHANTERIC FRACTURES WERE INTRAMEDDULARY NAIL (PFN/PFNA) IN 41 PATIENTS IN STABLE GROUP AND 54 PATIENTS IN UNSTABLE GROUP, DHS WAS USED IN 5 PATIENT IN STABLE GROUP, AND PF-LCP WAS USED IN 1 PATIENT IN STABLE GROUP AND 2 PATIENTS IN UNSTABLE GROUP. THE AVERAGE FOLLOW-UP DURATIONS WERE 60.62 ± 14.23 MONTHS AND 58.80 ± 13.09 MONTHS, RESPECTIVELY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES PFN, PFNA, DHS, LCP. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: FEMORAL NAIL (QTY 95): (N=95) IMPLANTED WITH PFN/PFNA HAD FIXATION FAILURE AND UNDERWENT HIP ARTHROPLASTY (HA) FOR REVISION SURGERY. FIXATION FAILURE IS EITHER NONUNION/PSEUDARTHROSIS, AVN/HEAD COLLAPSE, OR OSTEOARTHRITIS. HOWEVER, THE ARTICLE DOES NOT PROVIDE ENOUGH INFORMATION TO CATEGORIZE THE QUANTITY OF THE FAILURES FOR EACH PRODUCT TYPE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: DHS/DCS (QTY 5): (N=5) IMPLANTED WITH DHS HAD FIXATION FAILURE AND UNDERWENT HIP ARTHROPLASTY (HA) FOR REVISION SURGERY. FIXATION FAILURE IS EITHER NONUNION/PSEUDARTHROSIS, AVN/HEAD COLLAPSE, OR OSTEOARTHRITIS. HOWEVER, THE ARTICLE DOES NOT PROVIDE ENOUGH INFORMATION TO CATEGORIZE THE QUANTITY OF THE FAILURES FOR EACH PRODUCT TYPE ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: LCP (QTY 3): (N=3) IMPLANTED WITH PF-LCP HAD FIXATION FAILURE AND UNDERWENT HIP ARTHROPLASTY (HA) FOR REVISION SURGERY. FIXATION FAILURE IS EITHER NONUNION/PSEUDARTHROSIS, AVN/HEAD COLLAPSE, OR OSTEOARTHRITIS. HOWEVER, THE ARTICLE DOES NOT PROVIDE ENOUGH INFORMATION TO CATEGORIZE THE QUANTITY OF THE FAILURES FOR EACH PRODUCT TYPE ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - NAIL HEAD ELEMENTS: PFNA BLADE (QTY 1): (N=1) A CASE HAD PFNA INTERNAL FIXATION FAILED DUE TO CUT-OUT. FOLLOWING THE FAILURE OF THE INTERNAL FIXATION FOR THE INTERTROCHANTERIC FEMORAL FRACTURE, A PERIPROSTHETIC FRACTURE OCCURRED DURING HIP ARTHROPLASTY (REVISION SURGERY). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - NAIL HEAD ELEMENTS: PFNA BLADE (QTY 1): (N=1) ONE CASE EXPERIENCED PFNA FAILURE ONE MONTH POST-OPERATION DUE TO CUT-OUT, SUBSEQUENTLY UNDERWENT LEFT TOTAL HIP ARTHROPLASTY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - NAIL HEAD ELEMENTS. FOR THE FIXATION FAILURES OF CUTTING OUT/THROUGH OR METAL BREAKAGE/MIGRATION, THE ARTICLE DOES NOT PROVIDE ENOUGH INFORMATION TO CATEGORIZE THE QUANTITY OF THE FAILURES FOR EACH PRODUCT TYPE. THESE FAILURES ARE CAPTURED ON AN UNKNOWN HEAD ELEMENT UNTIL FURTHER INFORMATION IS PROVIDED BY THE AUTHORS. (N=49) CUTTING OUT/THROUGH CASES THAT UNDERWENT HIP ARTHROPLASTY (HA) FOR REVISION SURGERY. (N=21) METAL BREAKAGE/MIGRATION (EXACT QUANTITIES OF EACH ARE NOT PROVIDED) CASES THAT UNDERWENT HIP ARTHROPLASTY (HA) FOR REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81389 UNK - NAIL HEAD ELEMENTS ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention