BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TIBIAL STEM

    MDR report key: 24746158 · Received March 31, 2026

    Report

    Report Number
    0001822565-2026-01027
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    May 28, 2025
    Report Date
    March 31, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. D10: UNKNOWN - UNKNOWN ARTICULAR SURFACE - UNKNOWN. UNKNOWN - UNKNOWN FEMORAL - UNKNOWN. UNKNOWN - UNKNOWN FEMORAL STEM - UNKNOWN. UNKNOWN - UNKNOWN TIBIA - UNKNOWN. G2: FOREIGN - EVENT OCCURRED IN CANADA. G2: LITERATURE - GREENBERG, A., BRAUNSTEIN, D., ABUGHADUMA, N.R., GROSS, A., SAFIR, O., KUZYK, P., WOLFSTADT, J., BACKSTEIN, D. (2025). SURVIVORSHIP AND COMPLICATIONS IN REVISION TOTAL KNEE ARTHROPLASTY WITH A CONSTRAINED CONDYLAR KNEE IMPLANT: A MINIMUM 10-YEAR FOLLOW-UP STUDY. THE JOURNAL OF ARTHROPLASTY, VOLUME 40, ISSUE 12, 3240 - 3245. DOI: 10.1016/J.ARTH.2025.05.088. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THREE PATIENTS EXPERIENCED MINOR INFECTIONS AND LOCALIZED PAIN WHICH WERE TREATED CONSERVATIVELY WITHOUT FURTHER SURGICAL INTERVENTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800415 UNKNOWN TIBIAL STEM PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention