BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL STEM ACTIS

    MDR report key: 17895946 · Received October 9, 2023

    Report

    Report Number
    1818910-2023-20500
    Event Type
    Injury
    Date Received
    October 9, 2023
    Date of Event
    July 19, 2023
    Report Date
    October 9, 2023
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). D4: THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. 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 DEVICE HISTORY LOT: 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. H6: COMPONENT CODE: APPROPRIATE TERM/CODE NOT AVAILABLE (G07002) USED TO CAPTURE NO FINDINGS AVAILABLE. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: STRAIT AV, HO H, PARKS NL, HAMILTON WG, MCASEY CJ, SERSHON RA. DOES POWERED FEMORAL BROACHING COMPROMISE PATIENT SAFETY IN TOTAL HIP ARTHROPLASTY? ARTHROPLAST TODAY. 2023 SEP 19;23:101198. DOI: 10.1016/J.ARTD.2023.101198. PMID: 37745960; PMCID: PMC10514414. OBJECTIVE AND METHODS: TO ADDRESS CONCERNS WITH MANUAL FEMORAL BROACHING (MB) IN TOTAL HIP ARTHROPLASTY (THA), WHERE OFF-AXIS FORCES AND BROACH MALALIGNMENT CAN LEAD TO FEMUR FRACTURES AND CORTICAL PERFORATIONS, AUTHORS SOUGHT TO COMPARE THE RISKS AND BENEFITS OF POWERED BROACHING (PB) AS A NOVEL ALTERNATIVE, DELIVERING CONSISTENT IMPACTION FORCES AND REDUCING SURGEON WORKLOAD. THE STUDY COMPARED INTRAOPERATIVE AND 90-DAY RATES OF PERIPROSTHETIC FEMUR FRACTURES (PFFS) AND FEMORAL PERFORATIONS (FP) IN THA PERFORMED USING MB VS PB. AUTHORS REVIEWED ALL PATIENTS UNDERGOING PRIMARY CEMENTLESS DIRECT ANTERIOR THA FROM 2016 TO 2021, INVOLVING 2048 THAS (MB = 800; PB = 1248), USING THE DEPUY ACTIS FEMORAL STEM COMPONENTS (ACETABULAR COMPONENTS/MANUFACTURER WERE NOT IDENTIFIED). PFFS AND FPS WITHIN 90 DAYS OF THE INDEX PROCEDURE WERE COMPARED. DIFFERENCES IN LENGTH OF SURGERY AND DEMOGRAPHICS WERE ASSESSED. RESULTS: CALCAR FRACTURES OCCURRED IN <1% OF PATIENTS (PB [0.96%, 12/1248] VS MB [0.25%, 2/800]). RATES OF TROCHANTERIC FRACTURES DID NOT DIFFER (PB = 0.32% [4/1248] VS MB = 0.38% [3/800]). CORTICAL PERFORATIONS OCCURRED IN 0.24% (3/1248) OF THE PB COHORT AND IN 0.75% (6/800) OF THE MB COHORT. NO REVISIONS DUE TO ASEPTIC LOOSENING OR PFF OCCURRED WITHIN 120 DAYS OF SURGERY. CANAL PERFORATIONS WERE ADDRESSED WITH A SUITABLE LENGTH STEM THAT PASSED THE PERFORATION SITE. THE GREATER TROCHANTER FRACTURES WERE ALL TREATED CONSERVATIVELY, WITH NO ADDITIONAL INTERVENTIONS. CALCAR FRACTURES WERE ALL ADDRESSED WITH INTRAOPERATIVE CERCLAGE WIRES. CONCLUSION: THE AUTHORS¿ STUDY DEMONSTRATED THAT AT THEIR INSTITUTION, POWERED FEMORAL BROACHING IN THA IS A SAFE AND EFFICIENT MEANS OF PERFORMING DIRECT ANTERIOR THA. LOW RATES (<1%) OF PFF, PERFORATION, AND REVISION CAN BE ACHIEVED. GIVEN THEIR POSITIVE EXPERIENCE WITH PB, ALL SURGEON AUTHORS UTILIZE PB EXCLUSIVELY FOR ELECTIVE PRIMARY DIRECT ANTERIOR THA. COMPLICATIONS: POWERED BROACHING GROUP CASE #: ADVERSE EVENT. 1 GREATER TROCH FRACTURE. 24 CALCAR FRACTURE. 100 CALCAR FRACTURE. 133 GREATER TROCH FRACTURE. 175 PERFORATION. 227 CALCAR FRACTURE. 332 CALCAR FRACTURE. 359 GREATER TROCH FRACTURE. 388 CALCAR FRACTURE. 389 GREATER TROCH FRACTURE. 530 CALCAR FRACTURE. 634 CALCAR FRACTURE. 680 PERFORATION. 744 PERFORATION. 769 CALCAR FRACTURE. 836 CALCAR FRACTURE. 881 CALCAR FRACTURE. 999 CALCAR FRACTURE. 1073 CALCAR FRACTURE. MANUAL BROACHING GROUP. CASE #: ADVERSE EVENT. 111 PERFORATION. 123 CALCAR FRACTURE. 173 CALCAR FRACTURE. 204 PERFORATION. 245 PERFORATION. 343 PERFORATION. 350 PERFORATION. 352 PERFORATION. 453 GREATER TROCH FRACTURE. 557 GREATER TROCH FRACTURE. 622 GREATER TROCH FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866862 UNK HIP FEMORAL STEM ACTIS FEMORAL STEM LPH DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention