BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: LCP

    MDR report key: 21218044 · Received January 23, 2025

    Report

    Report Number
    8030965-2025-00814
    Event Type
    Injury
    Date Received
    January 23, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, (01)GTIN IS NOT AVAILABLE.

    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 T, DAI Z, MA Q, ZHOU H, LI H, ZHANG Z. SURGICAL OUTCOMES OF PROXIMAL FEMORAL BONE CYSTS IN PEDIATRIC PATIENTS: A RETROSPECTIVE STUDY OF 41 CASES. FRONT PEDIATR. 2024 JUN 24;12:1331089. DOI: 10.3389/FPED.2024.1331089. PMID: 38978837; PMCID: PMC11228295. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE SURGICAL OUTCOMES OF PROXIMAL FEMORAL BONE CYSTS IN PEDIATRIC PATIENTS. BETWEEN 2009 AND 2021, A TOTAL OF 41 PATIENTS (31 MALE AND 10 FEMALE) WITH A MEAN AGE OF 7.47 ± 2.67 YEARS, RANGING FROM 2.03 TO 14.67 YEARS. 31 PATIENTS WERE STABILIZED WITH LCP-PHP, 7 PATIENTS WITH FLEXIBLE INTRAMEDULLARY NAILS (FINS), AND 3 PATIENTS UNDERWENT ONLY BIOPSY AND BONE GRAFTING. THE AVERAGE FOLLOW-UP DURATION WAS 26.51 ± 18.99 MONTHS, WITH A RANGE OF 12.20 TO 82.13 MONTHS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES FLEXIBLE INTRAMEDULLARY NAILS AND LCP-PHP. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: LCP (QTY 1): IN A 6.76-YEAR-OLD FEMALE, THE RADIOGRAPH AT 1.9 YEARS POST-SURGERY, REVEALING PREMATURE CLOSURE OF THE EPIPHYSIS, SHORTENING OF THE FEMORAL NECK, AND COXA VARA. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: FEMORAL NAIL (QTY 1): IN A 8.7-YEAR-OLD MALE, THE RADIOGRAPH AT 2.2 YEAR POST-SURGERY SHOWING LLD WITH THE RIGHT FEMUR BEING 2CM SHORTER. RADIOGRAPH AT 5.4 YEARS POST-SURGERY, HIGHLIGHTING PREMATURE CLOSURE OF THE EPIPHYSIS, DEFORMITY DUE TO FEMORAL NECK SHORTENING, ELEVATED POSITION OF THE GREATER TROCHANTER (HIGH RIDING), AND COXA VARA. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: LCP (QTY 4): 4 PATIENTS HAD RECURRENCE. REQUIRED ADDITIONAL CURETTAGE AND BONE GRAFTING DUE TO PERSISTENT OR RECURRENT LESIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953281 UNK - CONSTRUCTS: LCP PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention