BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN ARTICULAR SURFACE SIZE F 10 MM HEIGHT

    MDR report key: 22308132 · Received June 23, 2025

    Report

    Report Number
    0001822565-2025-02066
    Event Type
    Injury
    Date Received
    June 23, 2025
    Date of Event
    June 13, 2025
    Report Date
    September 8, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) D4 / G4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO ITEM # 00596204014 (K042271), GTIN: (B)(4). G2: FOREIGN COUNTRY: AUSTRIA. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: B4; B5; D2; G1; G3; G6; H1; H2; H3; H4; H6. THE EVENT IS CONFIRMED. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED WEAR AND GOUGING ON A MATING CONDYLE AS WELL AS THE POST OF THE ARTICULAR SURFACE IS FRACTURED OFF THE BODY OF THE DEVICE. AS THE DEVICE WAS NOT RETURNED, FURTHER EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS AND RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RADIOGRAPHIC RECORDS IDENTIFIED THE FOLLOWING: RIGHT KNEE FEMOROTIBIAL ARTHROPLASTY COMPONENTS ARE PRESENT, EXHIBITING NARROWING OF THE MEDIAL FEMOROTIBIAL JOINT COMPARTMENT. THIS NARROWING SUGGESTS POLYETHYLENE LINER WEAR OR FRACTURE. EXCESSIVE POSTERIOR SLOPE OF THE TIBIAL COMPONENT IS NOTED, WHICH MAY BE A RISK FACTOR FOR ABNORMAL POLYETHYLENE STRESS/WEAR. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. APPROXIMATELY 17 YEARS POST-OP, THE PATIENT WAS REVISED DUE TO A POLY FRACTURE. ONLY THE POLY WAS REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    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
    754875 NEXGEN ARTICULAR SURFACE SIZE F 10 MM HEIGHT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 60942766

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11