BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FB SZ 1 RT 6MM

    MDR report key: 19182308 · Received April 25, 2024

    Report

    Report Number
    1038671-2024-00980
    Event Type
    Injury
    Date Received
    April 25, 2024
    Date of Event
    February 21, 2024
    Report Date
    January 31, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    UDI-DI
    10885862276339
    PMA / PMN Number
    K152217
    Removal / Correction Number
    Z-0024-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND/OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0024-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY."

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 5811135 350-02-01 - TALAR IMPLANT SZ 1 RT. 5969045 350-10-02 - ANKLE SZ 2 LOCKING CLIP. 6107919 350-12-02 - TIBIAL PLATE FB SZ 2 RT. H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR OF THE TIBIAL INSERT. THE CAUSE OF PROSTHESIS WEAR IS GENERALLY A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD A RIGHT ANKLE REPLACEMENT PROCEDURE ON (B)(6) 2019 AND THEN WAS REVISED ON (B)(6) 2024. THE PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE PROSTHESIS WEAR. THE MOSTLY LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROSTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855299 TIBIAL INSERT FB SZ 1 RT 6MM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC. 10885862276339

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Hospitalization| R SEE H10.