BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LINER

    MDR report key: 21835057 · Received April 14, 2025

    Report

    Report Number
    0009613350-2025-00297
    Event Type
    Injury
    Date Received
    April 14, 2025
    Report Date
    April 14, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D6A. IMPLANT DATE: BETWEEN JUL 1, 2007, AND FEB 28, 2018. D10: UNKNOWN BALL. G2. REPORT SOURCE: CANADA. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. A REVIEW OF THE COMPLAINT HISTORY COULD NOT BE PERFORMED DUE TO MISSING REFERENCE AND LOT NUMBERS. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. JOURNAL ARTICLE REPORTS THAT 43 YR OLD FEMALE PATIENT DISLOCATED AT 11 MONTHS POST-OP AND UNDERWENT TO REVISION FOR A CONSTRAINED POLYETHYLENE LINER. NO ADDITIONAL COMPLICATIONS WERE REPORTED. THE INVESTIGATION FOCUSED ON DISLOCATION AND REVISION SURGERY AS THIS IS CONSIDERED A SERIOUS INJURY. A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. ''LITERATURE: THE WAGNER CONE STEM FOR ATYPICAL FEMORAL ANATOMY IN TOTAL HIP ARTHROPLASTY. B. KAYANI, MICHAEL E. NEUFELD, M. BAUTISTA, L. C. HOWARD, M. ABDELMALEK, N. V. GREIDANUS, B. A. MASRI, D. S. GARBUZ. THE JOURNAL OF BONE AND JOINT SURGERY. PAGES (1-19).2024. HTTP://DX.DOI.ORG/10.2106/JBJS.23.00849.''

    Description of Event or Problem · 0

    ON 17 MAR 2025, A JOURNAL ARTICLE WAS RETRIEVED FROM THE JOURNAL OF BONE AND JOINT SURGERY, INC. 2024 THAT REPORTED A STUDY FROM CANADA. THE PURPOSE OF THE STUDY WAS TO DETERMINE THE IMPLANT SURVIVORSHIP, PATIENT SATISFACTION, FUNCTIONAL OUTCOMES, OSSEOINTEGRATION AS SEEN RADIOGRAPHICALLY, IMPLANT SUBSIDENCE, AND COMPLICATIONS OF THA USING THE WAGNER CONE PROSTHESIS STEM AT INTERMEDIATE-TERM FOLLOW-UP. THE RETROSPECTIVE STUDY REVIEWED 302 PATIENTS WHO UNDERWENT A TOTAL OF 320 PRIMARY THAS USING THE WAGNER CONE PROSTHESIS BETWEEN JULY 2007-FEBRUARY 2018. THE INDICATION FOR SURGERY WAS PROXIMAL FEMORAL DEFORMITIES, INCLUDING DEVELOPMENTAL HIP DYSPLASIA AND LEGG-CALVE-PERTHES DISEASE. THE STUDY POPULATION HAD A MEAN AGE OF 49.4 YEARS AT TIME OF SURGERY (RANGE 18.8-85.6); (NUMBER OF MALES/FEMALES). FOLLOW-UP WAS CONDUCTED POSTOPERATIVELY AT 6 WEEKS, 1 YEAR, AND THE TIME OF FINAL FOLLOW-UP WITH A MEAN LENGTH OF FOLLOW-UP FOR 10.1 YEARS (RANGE 5.2-15.5). IT WAS REPORTED THAT PATIENT UNDERWENT HIP REVISION APPROXIMATELY 11 MONTHS POST IMPLANTATION DUE TO A DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022849 UNKNOWN LINER PROSTHESIS, HIP LZO ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Hospitalization| R SEE H11 NARRATIVE.