BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    UNKNOWN REVITAN-MODULAR FLUTED TAPERED STEM

    MDR report key: 20384969 · Received October 7, 2024

    Report

    Report Number
    0009613350-2024-00479
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    April 1, 2024
    Report Date
    March 25, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2. REPORT SOURCE: GERMANY. LITERATURE: REVISION TOTAL HIP ARTHROPLASTY USING A MODULAR FLUTED, TAPERED REVISION FEMORAL COMPONENT AND INTERLOCKING SCREWS IN VANCOUVER B3 PERIPROSTHETIC FRACTURES WITH INSUFFICIENT BONE AT THE ISTHMUS. B. FINK; A. AHMADIAN; F. H. SAX; P. SCHUSTER. THE BONE AND JOINT JOURNAL. PAGES (1-8). 2024. DOI:10.1302/0301-620X.106B4.BJJ-2023-0899.R1. 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; H2; H3; H6. 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. MEDICAL RECORDS WERE NOT PROVIDED. BASED ON THE RECEIVED JOURNAL ARTICLE, THE REPORTED EVENT CAN BE CONFIRMED A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THERE WAS ONE PATIENT WITHIN THE PAPROSKY TYPE IIIA DEFECT GROUP THAT DISPLAYED RADIOGRAPHIC EVIDENCE OF NON-PROGRESSIVE SUBSIDENCE, WHICH SUBSEQUENTLY STABILIZED WITHOUT INTERVENTION. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246763 UNKNOWN REVITAN-MODULAR FLUTED TAPERED STEM PROSTHESIS, HIP LZO ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown