BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANKLE SZ 4 LOCKING CLIP

    MDR report key: 22800987 · Received August 13, 2025

    Report

    Report Number
    1038671-2025-02753
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    July 18, 2025
    Report Date
    October 20, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    UDI-DI
    10885862302021
    PMA / PMN Number
    K152217
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D. THE DISASSEMBLY REPORTED WAS LIKELY THE RESULT OF IMPROPER ASSEMBLY DURING THE INDEX SURGERY. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    D10: (B)(6) 350-01-04 - TALAR IMPLANT SZ 4 LT. (B)(6) 350-11-04 - TIBIAL PLATE FB SZ 4 LT. (B)(6) 351-50-00 - MODEL TIBIA TALUS REPORT. (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. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 72 YO MALE PATIENT, WHO HAD THEIR LEFT ANKLE IMPLANTED, UNDERWENT A REVISION PROCEDURE. THE TIBIAL CLIP WAS FOUND ON A LATERAL X-RAY TO BE COMING OUT OF THE POLY. THE POLY WAS EXCHANGED WITH A NEW TIBIAL CLIP. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. NO DEVICE IMAGES WERE AVAILABLE. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1686051 ANKLE SZ 4 LOCKING CLIP PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC. 10885862302021

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention SEE H11.