BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL TOTAL ANKLE TIBIAL BASE COMPONENT

    MDR report key: 7399015 · Received April 5, 2018

    Report

    Report Number
    0001822565-2018-01784
    Event Type
    Injury
    Date Received
    April 5, 2018
    Date of Event
    December 23, 2016
    Report Date
    March 26, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSN
    PMA / PMN Number
    PNA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: MFR#0001822565-2018-01785 AND MFR#0001822565-2018-01786 CONCOMITANT PRODUCTS: TRABECULAR METAL TOTAL ANKLE TALAR COMPONENT PN00830002400 LN62990953, TRABECULAR METAL TOTAL ANKLE TIBIAL INSERT PN00830005400 LN62861441. (B)(6) THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS CLEARED FOR EXPORT ONLY, NOT FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510K NUMBER K120906. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED X-RAYS AND OP NOTES. PER THE OP REPORT, PATIENT HAD SOME ANTERIOR CARTILAGE DAMAGE, INCREASED PAIN, AND A CYST. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT ANKLE REPLACEMENT. SUBSEQUENTLY, THE PATIENT SUFFERED FROM RECURRING HETEROTOPIC OSSIFICATION ONE YEAR LATER. THE PATIENT UNDERWENT DEBRIDEMENT AND REQUIRES REPEAT RADIOABLATION. IT WAS ALSO REPORTED THE PATIENT SUFFERS FROM PAIN, MODERATE SWELLING/STIFFNESS, TIGHT LAXITY, GAIT ABNOMALITY AND RESTRICTION OF HINDFOOT MOTION. NO PLANS HAVE BEEN MADE FOR REVISION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243274 TRABECULAR METAL TOTAL ANKLE TIBIAL BASE COMPONENT PROSTHESIS, ANKLE HSN ZIMMER BIOMET, INC. N/A 63046939

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention