BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL CONSTRUCT BIPOLAR

    MDR report key: 21970421 · Received May 6, 2025

    Report

    Report Number
    1818910-2025-07172
    Event Type
    Injury
    Date Received
    May 6, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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: A1, A2, A3, A4: THERE ARE MULTIPLE PATIENTS. ALL KNOWN INFORMATION IS PROVIDED IN THE LITERATURE ARTICLE. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, (01) GTIN IS NOT AVAILABLE. H3, H6: THE DEVICE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: PANKRATZ C, CINTEAN R, HOFMANN M, BOITIN D, DEHNER C, GEBHARD F, SCHUETZE K. EARLY SURGICAL CARE OF THE ANTICOAGULATED HIP FRACTURE PATIENT WITHIN 24 HOURS. INJURY. 2024 DEC;55(12):111924. DOI: 10.1016/J.INJURY.2024.111924. EPUB 2024 SEP 28. PMID: 39395386. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY WAS TO HYPOTHESIZE THAT THE URGENT SURGICAL TREATMENT OF HIP FRACTURE PATIENTS ON ANTITHROMBOTIC MEDICATION IS SAFE AND IS NOT ASSOCIATED WITH INCREASED SERIOUS BLEEDING COMPLICATIONS. FOR THE PERIOD FROM 2015 TO 2021, WE RETROSPECTIVELY REVIEWED CLINICAL RECORDS OF 1142 PATIENTS WITH PROXIMAL FEMUR FRACTURES TREATED WITHIN 24 H OF ADMISSION TO OUR TRAUMA CENTER (MEAN AGE 80.4 ± 12.4 YEARS; 761 FEMALES, 381 MALES). THE COHORT COMPRISED 409 FEMORAL NECK AND 733 TROCHANTERIC FRACTURES, MANAGED WITH EITHER ARTHROPLASTY (N = 297), HIP-PRESERVING TECHNIQUES (N = 147), OR INTRAMEDULLARY NAILING (N =698). OF THE PATIENTS WHO WERE OPERATED WITHIN 24 H, 297 RECEIVED A HIP ARTHROPLASTY (CORAIL® HIP SYSTEM, SELF-CENTERING¿ BIPOLAR HEAD, OR CORAIL® HIP SYSTEM, PINNACLE® ACETABULAR CUP SYSTEM, CO. DEPUY SYNTHES, WEST CHESTER, PA, USA). THE MEAN FOLLOW - UP PERIOD WAS UNKNOWN. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY CORAIL® HIP SYSTEM, SELF-CENTERING¿ BIPOLAR HEAD, OR CORAIL® HIP SYSTEM, PINNACLE® ACETABULAR CUP SYSTEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CONSTRUCT PINNACLE (QTY.35) -35 PATIENTS HAD POSTOPERATIVE HAEMATOMA THAT REQUIRED SURGICAL REVISIONS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL CONSTRUCT BIPOLAR (QTY.35) -35 PATIENTS HAD POSTOPERATIVE HAEMATOMA THAT REQUIRED SURGICAL REVISIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2010899 UNK HIP FEMORAL CONSTRUCT BIPOLAR PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENT, POLYMER/METAL/POLYMER JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention