BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL STEM RECLAIM PROXIMAL BODY

    MDR report key: 19875587 · Received July 31, 2024

    Report

    Report Number
    1818910-2024-16530
    Event Type
    Injury
    Date Received
    July 31, 2024
    Date of Event
    March 23, 2023
    Report Date
    July 31, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: POMEROY E, LIM JBT, VASARHELYI EM, NAUDIE DDR, LANTING B, MACDONALD SJ, MCCALDEN RW, HOWARD JL. NO DIFFERENCE IN SUBSIDENCE BETWEEN MODERN MONOBLOCK AND MODULAR TITANIUM FLUTED TAPERED FEMORAL STEMS. J ARTHROPLASTY. 2023 JUL;38(7S):S223-S228. DOI: 10.1016/J.ARTH.2023.03.034. EPUB 2023 MAR 23. PMID: 36963526. UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. H6 COMPONENT CODE: APPROPRIATE TERM/CODE NOT AVAILABLE (G07002) USED TO CAPTURE NO FINDINGS AVAILABLE. 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. 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: POMEROY E, LIM JBT, VASARHELYI EM, NAUDIE DDR, LANTING B, MACDONALD SJ, MCCALDEN RW, HOWARD JL. NO DIFFERENCE IN SUBSIDENCE BETWEEN MODERN MONOBLOCK AND MODULAR TITANIUM FLUTED TAPERED FEMORAL STEMS. J ARTHROPLASTY. 2023 JUL;38(7S):S223-S228. DOI: 10.1016/J.ARTH.2023.03.034. EPUB 2023 MAR 23. PMID: 36963526. OBJECTIVE/METHODS/STUDY DATA: THIS RETROSPECTIVE OBSERVATIONAL COHORT STUDY AIMS TO COMPARE STEM SUBSIDENCE ACROSS 3 MODERN TAPERED FLUTED TITANIUM (TFT) STEMS. OUR SECONDARY AIM WAS TO INVESTIGATE THE INFLUENCE OF BICORTICAL CONTACT OR ¿SCRATCH FIT¿ ON SUBSIDENCE, AS WELL AS THE ROLE OF INTRAOPERATIVE IMAGING IN MAXIMIZING BICORTICAL CONTACT AND PREVENTING STEM SUBSIDENCE. BETWEEN JANUARY 1ST 2013 AND SEPTEMBER 30TH 2021, A TOTAL OF 271 HIP ARTHROPLASTIES UTILIZING MODERN TFT STEMS AT A SINGLE INSTITUTION WERE INCLUDED IN THE STUDY. AMONG THESE, THE MONOBLOCK TFT STEM (REDAPT, SMITH & NEPHEW, MEMPHIS, TENNESSEE, USA) WAS USED IN 91 HIPS, WHILE MODULAR TFTS STEMS (RECLAIM, DEPUY, WARSAW, INDIANA, USA/RESTORATION MODULAR, STRYKER, KALAMAZOO, MICHIGAN, USA) WERE USED IN 180 HIPS (90 IN EACH GROUP). THE MEAN AGE WAS 70 (35-95), 70 (43-93), AND 71 (47-89) YEARS, RESPECTIVELY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES RECLAIM TAPERED FLUTED TITANIUM (TFT) STEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL CONSTRUCT RECLAIM (QTY 15): (N=12) PROSTHETIC JOINT INFECTION (PJI); UNDERWENT RE-REVISION OF WHICH (N=4) HAD RE-REVISION OF STEM (N=2) INSTABILITY; UNDERWENT RE-REVISION (N=1) OTHER/UNSPECIFIED EVENT; UNDERWENT RE-REVISION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL STEM RECLAIM DISTAL STEM (QTY 27) (N=19) HAD SUBSIDENCE >5MM, AND (N=8) HAD SUBSIDENCE >10MM. AMONG THEM, (N=1) UNDERWENT RE-REVISION OF THE STEM ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL STEM RECLAIM PROXIMAL BODY (QTY 27) (N=19) HAD SUBSIDENCE >5MM, AND (N=8) HAD SUBSIDENCE >10MM. AMONG THEM, (N=1) UNDERWENT RE-REVISION OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240071 UNK HIP FEMORAL STEM RECLAIM PROXIMAL BODY FEMORAL STEM LPH DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention