BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LINER

    MDR report key: 21799320 · Received April 8, 2025

    Report

    Report Number
    0009613350-2025-00249
    Event Type
    Injury
    Date Received
    April 8, 2025
    Report Date
    April 21, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H6, H10, H11. 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 58-YEAR-OLD FEMALE PATIENT WITH CHRONIC DISLOCATION AT 6.2 YEARS POST-OPERATION WHO UNDERWENT A GIRDLESTONE PROCEDURE. NO ADDITIONAL COMPLICATIONS WERE REPORTED AT THE 5.6-YEAR FOLLOW-UP. THE INVESTIGATION FOCUSED ON THE CHRONIC DISLOCATION AND SUBSEQUENT GIRDLESTONE PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D6A. IMPLANT DATE: BETWEEN (B)(6) 2007 AND (B)(6) 2018. D10. UNKNOWN HEAD ITEM# UNKNOWN LOT# UNKNOWN. G2. REPORT SOURCE: CANADA. ''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.'' THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    DILIGENCE IS COMPLETE AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    ON 17MAR2025, 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 IN A JOURNAL ARTICLE THAT ONE PATIENT HAD CHRONIC DISLOCATION AT 6.2YRS POST-OP AND UNDERWENT A GIRDLESTONE PROCEDURE. NO ADDITIONAL COMPLICATIONS WERE REPORTED AT 5.6YR FOLLOW-UP. DILIGENCE IS COMPLETE AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446935 UNKNOWN LINER PROSTHESIS, HIP LZO ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Hospitalization| R SEE H11 NARRATIVE.