BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PFNA-II

    MDR report key: 20042927 · Received August 22, 2024

    Report

    Report Number
    8030965-2024-10268
    Event Type
    Injury
    Date Received
    August 22, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. B5: DOI LINK PROVIDED IN EVENT DESCRIPTION CAN BE PASTED INTO AN INTERNET BROWSER TO ACCESS THIS LITERATURE ARTICLE. D4, G4 - 510K: THIS REPORT IS FOR AN UNKNOWN PFNA-II CONSTRUCT/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H6: 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. 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 COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KWAK DK, LEE S, LEE KU, YOO JH. INCIDENCE AND RISK FACTORS OF OSTEONECROSIS OF THE FEMORAL HEAD AFTER CEPHALOMEDULLARY NAILING FOR PERTROCHANTERIC FRACTURES: OBSERVATIONAL SINGLE-CENTER STUDY. CLIN ORTHOP SURG. 2024 JUN;16(3):397-404. DOI: 10.4055/CIOS23287. EPUB 2024 APR 22. PMID: 38827762; PMCID: PMC11130631. OBJECTIVE/METHODS/STUDY DATA: THIS RETROSPECTIVE COHORT STUDY WAS APPROVED BY THE INSTITUTIONAL REVIEW BOARD OF HALLYM UNIVERSITY SACRED HEART HOSPITAL (NO. 2018-07-014). REQUIREMENT FOR INFORMED CONSENT WAS WAIVED OWING TO ITS RETROSPECTIVE NATURE. A PROSPECTIVELY COMPILED DATABASE WAS USED TO RECRUIT PATIENTS WHO UNDERWENT CEPHALOMEDULLARY NAILING FOR PERTROCHANTERIC HIP FRACTURES AT OUR HOSPITAL BETWEEN MAY 2010 AND JULY 2019. THEN, PATIENTS WHO MET THE FOLLOWING INCLUSION CRITERIA WERE INCLUDED: (1) AGE = 65 YEARS AT THE TIME OF INJURY, (2) INDEPENDENTLY OR DEPENDENTLY AMBULATORY PRIOR TO INJURY, (3) PERTROCHANTERIC FRACTURES TREATED WITH CEPHALOMEDULLARY NAILING, (4) BONY UNION OBTAINED WITHOUT FIXATION FAILURE, AND (5) AVAILABLE POSTOPERATIVE FOLLOW-UP RECORDS FOR AT LEAST 12 MONTHS. PATIENTS WITH MULTIPLE TRAUMA AND PATHOLOGIC FRACTURES WERE EXCLUDED. DURING THIS PERIOD, 689 CONSECUTIVE PATIENTS WHO UNDERWENT CEPHALOMEDULLARY NAILING FOR PERTROCHANTERIC FRACTURES WERE IDENTIFIED. OF THESE, 368 PATIENTS WHO MET THE INCLUSION CRITERIA WERE FINALLY ENROLLED WITH A MEAN FOLLOW-UP OF 28.6 ± 17.3 MONTHS. A TOTAL OF 254 FEMALE AND 114 MALE PATIENTS WITH A MEAN AGE OF 77.8 ± 13.9 YEARS WERE RETROSPECTIVELY ANALYZED. AGE, SEX, BODY MASS INDEX (BMI), BONE MINERAL DENSITY (BMD). REGARDING THE TYPES OF THE NAILS USED, A NAIL WITH A THREAD-TYPE LAG SCREW (INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION SYSTEM, ZIMMER) WAS USED IN 28 PATIENTS (7.6%), A NAIL WITH A HELICAL BLADE (PFNA-II, PROXIMAL FEMORAL NAIL ANTIROTATION; DEPUY SYNTHES) IN 24 PATIENTS (6.5%), A NAIL WITH A HYBRID-TYPE LAG SCREW (GAMMA3 U-BLADE, STRYKER) IN 267 PATIENTS (72.6%), AND A NAIL WITH A LAG SCREW AND ADDITIONAL ANTIROTATION SCREW (AFFIXUS, BIOMET TRAUMA) IN 49 PATIENTS (13.3%). WE DID NOT USE BONE CEMENT OR CALCIUM PHOSPHATE INTRAOPERATIVELY IN ALL PATIENTS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES HELICAL BLADE (PFNA-II, PROXIMAL FEMORAL NAIL ANTIROTATION) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: PFNA-II (QTY 1) -1 PATIENT (WITH A HELICAL BLADE/PFNA-II) DEVELOPED OSTEONECROSIS OF THE FEMORAL HEAD; INTERVENTION WAS NOT SPECIFIED, BUT AMONG THE 9 PATIENTS WHO HAD OSTEONECROSIS OF THE FEMORAL HEAD, 3 WERE CONVERTED TO ARTHROPLASTY. THIS REPORT IS FOR AN UNKNOWN PFNA-II CONSTRUCT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363905 UNK - CONSTRUCTS: PFNA-II ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention