BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK HIP FEMORAL STEM CHARNLEY

    MDR report key: 21856177 · Received April 17, 2025

    Report

    Report Number
    1818910-2025-05724
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    December 9, 2024
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY ORTHOPAEDICS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY ORTHOPAEDICS HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY ORTHOPAEDICS OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY ORTHOPAEDICS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. INVESTIGATION SUMMARY: 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. DEVICE HISTORY: THE DEVICE LOT IS UNKNOWN; THEREFORE, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED. 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: PEREZ ALAMINO L, GARABANO G, RODRIGUEZ J, LOPREITE F, PESCIALLO C. [TRANSLATED ARTICLE] TOTAL HIP ARTHROPLASTY IN PATIENTS UNDER 50 YEARS OLD: DOES CEMENTLESS FIXATION HAVE BETTER RESULTS? REV ESP CIR ORTOP TRAUMATOL. 2025 MAR-APR;69(2): T142-T149. ENGLISH, SPANISH. DOI: 10.1016/J.RECOT.2024.12.008. EPUB 2024 DEC 9. PMID: 39653139. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS RETROSPECTIVE COMPARATIVE STUDY WAS TO COMPARE THE LONG-TERM RESULTS THREE DIFFERENT TYPES OF FIXATIONS IN PATIENTS UNDER 50 YEARS OLD. BETWEEN FEBRUARY 2005 AND JANUARY 2012, A TOTAL OF 222 PATIENTS (107 MALE AND 115 FEMALE) WHO UNDERWENT PRIMARY THA FOR OSTEOARTHRITIS OF THE HIP AND WHO COMPLETED A MINIMUM FOLLOW-UP OF 8 YEARS WERE INCLUDED. THE TYPES OF PROSTHESES USED IN THIS SERIES WERE: GROUP A: OGEE CUP WITH CEMENTED CHARNLEY STEM (DEPUY, WARSAW, IND, USA) IN 45 PATIENTS (18 MALE AND 27 FEMALE; MEAN AGE WAS 42.8 ± 7.2 YEARS, GROUP B: DURALOC CUP WITH CEMENTED CHARNLEY STEM (DEPUY, WARSAW, IND, USA) IN 69 PATIENTS (27 MALE AND 42 FEMALE; MEAN AGE WAS 42.9 ± 7.4 YEARS, AND GROUP C: TRIDENT CUP WITH CEMENTLESS ACCOLADE STEM (STRYKER, MAHAW, NJ, USA) IN 108 PATIENTS (62 MALE AND 46 FEMALE; MEAN AGE WAS 40.5 ± 7.2 YEARS). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES OGEE CUP, DURALOC CUP, AND CEMENTED CHARNLEY STEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CONSTRUCT OGEE (QTY 4): 1 PATIENT HAD PERIPROSTHETIC INFECTION. NO INTERVENTION NOTED. 1 PATIENT HAD PERIPROSTHETIC FRACTURE. NO INTERVENTION NOTED. 2 PATIENT HAD DEEP VEIN THROMBOSIS. NO INTERVENTION NOTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CONSTRUCT DURALOC (QTY 7): 1 PATIENT HAD LUXATION. NO INTERVENTION NOTED. 3 PATIENTS HAD PERIPROSTHETIC INFECTION. NO INTERVENTION NOTED. 1 PATIENT HAD PERIPROSTHETIC FRACTURE. NO INTERVENTION NOTED. 1 PATIENT HAD GLUTEAL INSUFFICIENCY (DEFINED BY THE PRESENCE OF THE TRENDELENBURG SIGN IN THE OPERATED HIP). NO INTERVENTION NOTED. 1 PATIENT HAD DEEP VEIN THROMBOSIS. NO INTERVENTION NOTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL CONSTRUCT CHARNLEY (QTY 11). 1 PATIENT IN GROUP A AND 3 IN GROUP B HAD PERIPROSTHETIC INFECTION. NO INTERVENTION NOTED. 1 PATIENT IN GROUP A AND 1 IN GROUP B HAD PERIPROSTHETIC FRACTURE. NO INTERVENTION NOTED. 2 PATIENT IN GROUP A AND 1 PATIENT IN GROUP B HAD DEEP VEIN THROMBOSIS. NO INTERVENTION NOTED. 1 PATIENT HAD LUXATION IN GROUP B. NO INTERVENTION NOTED. 1 PATIENT HAD GLUTEAL INSUFFICIENCY (DEFINED BY THE PRESENCE OF THE TRENDELENBURG SIGN IN THE OPERATED HIP) IN GROUP B. NO INTERVENTION NOTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CUP OGEE (QTY 9): 9 CASES HAD ACETABULAR LOOSENING, OF WHICH 4 PATIENTS REQUIRED REVISION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CUP DURALOC (QTY 3): 3 CASES WITH CUP LOOSENING WERE OBSERVED, IN PATIENTS WHO HAD UNDERGONE REVISION AT 10, 11, AND 12 YEARS, RESPECTIVELY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL STEM CHARNLEY (QTY 17): IN GROUP A, REGARDING THE BEHAVIOUR OF THE STEMS, 4 PATIENTS DEVELOPED SIGNS OF LOOSENING. NO INTERVENTION NOTED. IN GROUP B, REGARDING THE BEHAVIOUR OF THE STEMS, 13 PATIENTS DEVELOPED SIGNS OF LOOSENING. NO INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31650 UNK HIP FEMORAL STEM CHARNLEY FEMORAL STEM LPH DEPUY INTERNATIONAL LTD - 8010379

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown