BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT MB SZ 2 LT 6MM

    MDR report key: 18880310 · Received March 11, 2024

    Report

    Report Number
    1038671-2024-00456
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    February 14, 2024
    Report Date
    December 18, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    PMA / PMN Number
    K152217
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF A COMBINATION OF HIGH IN VIVO LOADING AND ANTERIOR IMPINGEMENT OF THE TIBIAL INSERT. ANTERIOR IMPINGEMENT MAY HAVE CAUSED A BENDING MOMENT, WHICH MAY HAVE LED TO THE INITIATION OF A CRACK ON THE LATERAL SIDE WHICH THEN PROPAGATED ACROSS THE INSERT MEDIALLY RESULTING IN PROSTHESIS FRACTURE. HOWEVER, THIS CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 5912352 - 350-01-02E - TALUSKAPPE 2, LI. 6410420 - 350-31-03 - TIBIAPLATEAU MOBIL 3, LI. 6330728 - 350-41-02 - TIBIA INLAY MOBIL 6 MM, 2, LI. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    CORRECTED: H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF MALALIGNMENT BETWEEN THE TIBIAL AND TALAR COMPONENTS, WHICH LED TO INCREASED IN VIVO STRESSES ON THE ANTEROLATERAL CORNER OF THE POLYETHYLENE COMPONENT. THIS LIKELY RESULTED IN TORSIONAL LOADING OF THE POLYETHYLENE COMPONENT LEADING TO CRACK INITIATION ON THE LATERAL SIDE, PROPAGATION, AND ULTIMATELY, PROSTHESIS FRACTURE. H6: INVESTIGATION CONCLUSION CODE. ADDITIONAL INFORMATION: H6: TYPE OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. 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 FOLLOWING SECTIONS WERE UPDATED: D4: UDI (B)(4). G4: 510K K152217 THE FOLLOWING SECTIONS WERE CORRECTED: B2 D1 H6 THE REVISION REPORTED WAS LIKELY THE RESULT OF MALALIGNMENT BETWEEN THE TIBIAL AND TALAR COMPONENTS, WHICH LED TO INCREASED IN VIVO STRESSES ON THE ANTEROLATERAL CORNER OF THE POLYETHYLENE COMPONENT. THIS LIKELY RESULTED IN TORSIONAL LOADING OF THE POLYETHYLENE COMPONENT LEADING TO CRACK INITIATION ON THE LATERAL SIDE, PROPAGATION, AND ULTIMATELY, PROSTHESIS FRACTURE. 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 A PATIENT, INITIAL LEFT ANKLE IMPLANTED ON (B)(6) 2021, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 2 YEARS 11 MONTHS POST THE INITIAL PROCEDURE. THE SURGEON HAD TO REVISE THE INSERT / INLAY DUE TO A BREAKAGE. NO PARTS OR PIECES FELL INTO THE PATIENT. THERE WERE NO SURGICAL DELAYS 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 DEVICE IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969252 TIBIAL INSERT MB SZ 2 LT 6MM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC. TIBIAL INSERT MB SZ 2 LT 6MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H10