BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK NEXGEN BEARING

    MDR report key: 22496184 · Received July 14, 2025

    Report

    Report Number
    0001822565-2025-02493
    Event Type
    Injury
    Date Received
    July 14, 2025
    Date of Event
    April 16, 2025
    Report Date
    July 25, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D2, D4, G4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. D10: ADDITIONAL ASSOCIATED PRODUCTS. UNK FEMORAL LOT# UNK. UNK TIBIAL LOT# UNK. G2: LITERATURE CITATION: OLSON, N. R., STRAIT, A. V., HO, H., FRICKA, K. B., HAMILTON, W. G., & SERSHON, R. A. (2025). NEW AND IMPROVED? ANALYSIS OF GENERATIONAL IMPLANT-RELATED FAILURES AND ALL-CAUSE REVISION INDICATIONS FOR TOTAL KNEE ARTHROPLASTY OVER A 30-YEAR PERIOD. THE JOURNAL OF ARTHROPLASTY. HTTPS://DOI.ORG/10.1016/J.ARTH.2025.04.046. THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN 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: B4, B5, G3, G6, H1, H2, H3, H6, H10, H11. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATIONS ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NONE WERE PROVIDED. INSUFFICIENT INFORMATION PROVIDED TO PERFORM A COMPATIBILITY CHECK. COMPLAINT HISTORY REVIEWS CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATIONS. MEDICAL RECORDS WERE NOT PROVIDED. COMPLAINT IS NOT CONFIRMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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 THROUGH THE STUDY THAT PATIENT IN THE GROUP EXPERIENCED EXTENSOR DISRUPTION RESULTING IN TOTAL KNEE REVISION.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278980 UNK NEXGEN BEARING PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11 NARRATIVE