BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FB SZ 2 RT 6MM

    MDR report key: 19416096 · Received May 29, 2024

    Report

    Report Number
    1038671-2024-01547
    Event Type
    Injury
    Date Received
    May 29, 2024
    Date of Event
    November 4, 2022
    Report Date
    January 29, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    PMA / PMN Number
    K152217
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 350-02-02 - TALAR IMPLANT SZ 2 RT 6843954. 350-10-03 - ANKLE SZ 3 LOCKING CLIP 6778708. 350-12-03 - TIBIAL PLATE FB SZ 3 RT 6827406. 351-90-20 - TUBERCLE PIN POUCH 6939736. 351-90-21 - 3.5"" PIN POUCH 6738350. 351-90-21 - 3.5"" PIN POUCH 6842893. 351-90-22 - 2.5"" PIN POUCH 6774603. 351-90-24 - TALAR TRIAL SCREW POUCH 7016073. 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. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: G2 H6. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE AVAILABLE INFORMATION BUT MAY HAVE BEEN REPORTED AT THIS LATER TIME DUE TO INCLUSION OF ONE OF THE IMPLANTED DEVICES IN THE PACKAGING RECALL. BASED ON LENGTH OF IMPLANTATION, THE REASON FOR REVISION APPEARS UNLIKELY TO BE SECONDARY TO PROSTHESIS WEAR. HOWEVER, THE REPORTED PROSTHESIS WEAR AND INSTABILITY COULD NOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF USER, OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED, AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. 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 VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 15 MONTHS AFTER A RIGHT TOTAL ANKLE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, INSTABILITY, VARUS DEFORMITY, ARTHRITIS, CYSTS, AND SCAR TISSUE.. INITIAL SURGERY AND 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
    629153 TIBIAL INSERT FB SZ 2 RT 6MM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H10