BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CONSTRUCT

    MDR report key: 25300466 · Received May 27, 2026

    Report

    Report Number
    1818910-2026-09236
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    April 3, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). 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. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT: (B)(4). 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. H11 ADDITIONAL NARRATIVE: 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. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TURNBULL G, BLACKLOCK C, AKHTAR A, DUNSTAN E, BALLANTYNE JA. EXPERIENCE OF AN ANATOMIC FEMORAL STEM IN A UK ORTHOPAEDIC CENTRE BEYOND 20 YEARS OF FOLLOW-UP. EUR J ORTHOP SURG TRAUMATOL. 2024 MAY;34(4):2155-2162. DOI: 10.1007/S00590-024-03901-1. EPUB 2024 APR 3. PMID: 38565783; PMCID: PMC11101503. OBJECTIVE/METHODS/STUDY DATA: THE PRIMARY AIM OF THIS STUDY WAS THEREFORE TO DETERMINE THE LONG-TERM SURVIVORSHIP AND PFF RATE OF THE LUBINUS SP II IN A SINGLE UNITED KINGDOM (UK) CENTRE WITH TWO DECADES EXPERIENCE OF IMPLANTING IT. BETWEEN 2000 AND 2002, 94 CONSECUTIVE PRIMARY THAS INCORPORATING A 170 MM LUBINUS SP II FEMORAL STEM WERE PERFORMED WITHIN OUR INSTITUTION. ALL OF THE OPERATIONS WERE PRIMARY, UNILATERAL THAS PERFORMED, OR SUPERVISED, BY ONE OF 6 DIFFERENT CONSULT ANT ORTHOPAEDIC SURGEONS WITH AN INTEREST IN LOWER LIMB ARTHROPLASTY. CEMENTED ELITE PLUS COMPONENTS (DEPUY SYNTHES) WERE USED IN ALL ACETABULA. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ELITE PLUS. OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: LUBINUS SP II. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP ACETABULAR CONSTRUCT (QTY: 6), N=3 INFECTION - TREATED WITH ANTIBIOTICS, N=3 POST-OP DVT - NO TREATMENT NOTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP ACETABULAR CUP (QTY: 2), N=2 ACETABULAR LOOSENING - REVISIONS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP ACETABULAR LINER (QTY: 5), N=5 DISLOCATION - UNDERGONE MODIFIED HARDINGE APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480564 UNKNOWN HIP ACETABULAR CONSTRUCT PROSTHESIS, HIP, SEMI-CONSTRAINED LZO DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1