BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITAN DIST. CURVED 20/200

    MDR report key: 24302033 · Received February 10, 2026

    Report

    Report Number
    0009613350-2026-00046
    Event Type
    Injury
    Date Received
    February 10, 2026
    Date of Event
    December 16, 2025
    Report Date
    February 23, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024503243
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D6A, D6B, G3, G6, H2, H11. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: A1, H6. THE FOLLOWING SECTIONS WERE UPDATED: A2, A4, B4, B5, B7, D4, D10, G3, G6, H2, H6, H11. D10: CONCOMITANT MEDICAL PRODUCTS: DESC: BIOLX OPT HD/ADPT 12/14 36X0; ITEM: 00-8777-036-02; LOT: 3099762. DESC: CABLE READY GTR COCR CABLE; ITEM: 00-2232-004-18; LOT: 65593159. DESC: CABLE READY GTR COCR CABLE; ITEM: 00-2232-004-18; LOT: 64888690. INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CONCOMITANT MEDICAL PRODUCTS: DESC: REVITAN PROX. CYLINDRICAL 55; ITEM: 01.00402.055; LOT: 13053950. G2: FOREIGN - EVENT OCCURRED IN GERMANY. INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A REVITAN SYSTEM IN THEIR LEFT HIP ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT REPORTED FELLING A 'CRACK IN THE LEFT HIP WHEN TURNING SHARPLY TO THE LEFT'. NO FALL WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363079 REVITAN DIST. CURVED 20/200 PROSTHESIS, HIP LZO ZIMMER GMBH 3012020 00889024503243

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| O SEE H11 NARRATIVE| SEE H11 NARRATIVE