BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN FITMORE STEM

    MDR report key: 19860325 · Received July 30, 2024

    Report

    Report Number
    0009613350-2024-00314
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    November 23, 2023
    Report Date
    August 26, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) G2 REPORT SOURCE : FOREIGN: SWITZERLAND LITERATURE : JANA F. SCHADER, CAROLINE THALMANN1, KATHARINA S. MAIER,TOM SCHIENER, KARL STOFEL2,3 & ARNO FRIGG (2023) PROSPECTIVE EVALUATION OF CLINICAL AND RADIOGRAPHIC 10-YEAR RESULTS OF FITMORE SHORT-STEM TOTAL HIP ARTHROPLASTY. JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH. (1-6). HTTPS://DOI.ORG/10.1186/S13018-023-04359-3. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G3; H1; H2; H3; H6 H1: THE STUDY REPORTED INCIDENTAL FINDINGS OF RADIOLUCENCY (17.5%), CALCAR ROUNDING (86.2%), RESORPTION (3.8%), SUBSIDENCE (5.0 ± 3.1) H3: PRODUCT INFORMATION IS UNKNOWN NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS 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 A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT RADIOGRAPHIC RESULTS AFTER 10 YEARS FOLLOW-UP HAD INCIDENTAL FINDINGS OF RADIOLUCENCY (17.5%), CALCAR ROUNDING (86.2%), RESORPTION (3.8%), SUBSIDENCE (5.0 ± 3.1). IN THIS INSTANCE, NO FURTHER PATIENT OUTCOME WAS REPORTED. HOWEVER, THIS EVENT IS RELATED TO A MALFUNCTION THAT HAS LED TO A SERIOUS INJURY IN THE PAST. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200728 UNKNOWN FITMORE STEM HIP PROTHESIS LZO ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11 NARRATIVE.