BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FB SZ 2 LT 8MM

    MDR report key: 20181065 · Received September 10, 2024

    Report

    Report Number
    1038671-2024-03412
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    January 24, 2024
    Report Date
    January 17, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    UDI-DI
    10885862276308
    PMA / PMN Number
    K152217
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    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. THE REPORTED PROSTHESIS WEAR COULD NOT BE CONFIRMED. 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, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. 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 (B)(4) 350-01-02 - TALAR IMPLANT SZ 2 LT. (B)(4) 350-10-03 - ANKLE SZ 3 LOCKING CLIP. (B)(4) 350-11-03 - TIBIAL PLATE FB SZ 3 LT. (B)(4) 351-91-03 - RECIP SAWBLADE 8X50X1MM. (B)(4) 351-91-04 - SAW-10X75X1.19-STRYKER. N/A 351-90-08 - 4.5"" VANTAGE PIN. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 52 MONTHS AFTER A LEFT TOTAL ANKLE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226154 TIBIAL INSERT FB SZ 2 LT 8MM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC. 10885862276308

    Patients

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