BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIM+ TIB-L-15MM-SZ4

    MDR report key: 23498988 · Received November 7, 2025

    Report

    Report Number
    1038671-2025-03291
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    October 16, 2025
    Report Date
    November 7, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    UDI-DI
    10885862623003
    PMA / PMN Number
    K230717
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 03-CNB-CD-0001 - V3D CORNER DRILL - ZH. 351-10-34 - TIBIAL BONE REMOVAL SCRW. 351-91-04 - SAW-10X75X1.19-STRYKER (B)(6). 351-91-03 - RECIP SAWBLADE 8X50X1MM (B)(6). 351-50-21 - PSI 3D PLUS TIBIA (B)(6). 350-01-03 - TALAR IMPLANT SZ 3 LT (B)(6). 350-23-43 - VIT E LINER-L-SZ 3-10MM (B)(6). 03-CMB-LC-0004 - P/P+ LOCKING CLIP - SZ4 (B)(6). 351-90-21 - 3.5" PIN POUCH (B)(6). 351-90-21 - 3.5" PIN POUCH (B)(6). 351-90-22 - 2.5" PIN POUCH (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL ANKLE ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING LIFTOFF OF THE TIBIAL PLATE. UPON A FOLLOW-UP APPOINTMENT WITH THE PATIENT THE SURGEON REPORTED "TIBIAL IMPLANT IS ALMOST COMPLETED SEATED NOW. GREAT ROM". NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181929 PRIM+ TIB-L-15MM-SZ4 PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC. 10885862623003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11.