BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TIBIAL TRAY

    MDR report key: 24743217 · Received March 31, 2026

    Report

    Report Number
    0001822565-2026-01013
    Event Type
    Injury
    Date Received
    March 31, 2026
    Report Date
    April 22, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NA
    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- MEDICAL PRODUCT. UNKNOWN ARTICULAR SURFACE. UNKNOWN FEMORAL. G2- CANADA. G2- 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. H3- 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 THROUGH A JOURNAL ARTICLE THAT TWELVE KNEES IMPLANTED WITH A CONSTRAINED CONDYLAR KNEE SYSTEM IN REVISION TOTAL KNEE ARTHROPLASTY WERE SUBSEQUENTLY REVISED DUE TO INFECTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801129 UNKNOWN TIBIAL TRAY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R