BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN HIP ACETABULAR LINERS

    MDR report key: 21959502 · Received May 5, 2025

    Report

    Report Number
    1818910-2025-07003
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    March 15, 2025
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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. 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: NAKAGAWA S, MIYAMOTO S, NAKATANI T, SUZUKI C, KAWAMOTO T, SHINADA Y, IIDA S. INCREASED RISK OF PERIPROSTHETIC FRACTURE ASSOCIATED WITH DECREASED ASEPTIC LOOSENING IN C-STEM COMPARED WITH THE CHARNLEY ELITE PLUS IN PRIMARY TOTAL HIP ARTHROPLASTY: A MINIMUM 10-YEAR FOLLOW-UP STUDY. BMC MUSCULOSKELET DISORD. 2025 MAR 15;26(1):264. DOI: 10.1186/S12891-025-08503-4. PMID: 40087633; PMCID: PMC11909823. THE RETROSPECTIVE CONSECUTIVE STUDY AIMED TO COMPARE CLINICAL (PERIPROSTHETIC FRACTURE [PPF] AND NEED FOR REVISION SURGERY) AND RADIOGRAPHIC (SUBSIDENCE, RADIOLUCENT LINES, AND AL) OUTCOMES BETWEEN THE ELITE PLUS AND C-STEM, WHICH WERE POTENTIALLY AFFECTED BY ALTERATIONS IN THE STEMS¿ DESIGN AND BEHAVIOR. STUDY CONDUCTED ON PRIMARY TOTAL HIP REPLACEMENTS WITH THE FEMORAL COMPONENT OF THE CHARNLEY ELITE PLUS AND C-STEM. A TOTAL OF 798 PRIMARY TOTAL HIP REPLACEMENTS WERE PERFORMED FROM AUGUST 1996 TO JUNE 2009. THE MEAN AGE AT SURGERY WAS 64.8 YEARS (RANGE, 42¿87) IN THE ELITE PLUS GROUP AND 61.5 YEARS (RANGE, 31¿83) IN THE C-STEM GROUP. THE ELITE PLUS GROUP INCLUDED 10 MEN AND 68 WOMEN, WHEREAS THE C-STEM GROUP COMPRISED 9 MEN AND 28 WOMEN.THE ACETABULAR COMPONENTS USED WERE CHARNLEY (DEPUY SYNTHES) IN 4 CASES, ELITE PLUS (DEPUY SYNTHES) IN 2 CASES, AND DURALOC (DEPUY SYNTHES) IN 83 CASES. THE BONE CEMENTS USED WERE ENDURANCE (DEPUY SYNTHES) IN 67 CASES, SIMPLEX (STRYKER CORP., USA) IN 10 CASES, AND UNKNOWN IN 12 CASES. THE MEAN FOLLOW-UP DURATIONS WERE 15.6 YEARS FOR THE ELITE PLUS GROUP AND 11.7 YEARS FOR THE C-STEM. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ACETABULAR COMPONENTS, CHARNLEY (DEPUY SYNTHES). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP ACETABULAR LINERS (QTY 14). (N=5) PATIENTS HAD DISLOCATION, NO INTERVENTION NOTED. (N=3) PATIENTS HAD ASEPTIC LOOSENING(AL), NO INTERVENTION NOTED. (N=2) UNKNOWN EVENT, RE-OPERATION OF THE ACETABULAR COMPONENTS. (N=4) UNKNOWN EVENT, REVISION ARTHROPLASTY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP FEMORAL STEM (QTY 2) (N=2) PATIENTS HAD STEM LOOSENING THAT REQUIRES RE-OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1832201 UNKNOWN HIP ACETABULAR LINERS HIP ACETABULAR LINERS LPH DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention