BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKREBALANCE TALAR COMPONENT

    MDR report key: 13364763 · Received January 27, 2022

    Report

    Report Number
    3002806535-2022-00032
    Event Type
    Injury
    Date Received
    January 27, 2022
    Report Date
    January 27, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HSN
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). INITIAL FINAL COMBINED REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. MEDICAL PRODUCT: UNK REBALANCE TIBIAL COMPONENT, CATALOG #: UNK, LOT #: UNK . MEDICAL PRODUCT: UNK REBALANCE BRG COMPONENT, CATALOG #: UNK, LOT #: UNK. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2022-000268, 3002806535-2022-00027. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. DEVICES ARE USED FOR TREATMENT. INSUFFICIENT INFORMATION PROVIDED. UNABLE TO PERFORM A COMPATIBILITY CHECK. COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. DEVICES REMAIN IMPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL ANKLE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT UNDERWENT GUTTER CLEANING/IMPINGEMENT. WE HAVE BEEN NOTIFIED THAT NO FURTHER INFORMATION AVAILABLE AS SURGEON HAS RETIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581345 UNKREBALANCE TALAR COMPONENT ANKLE ARTHROPLASTY HSN BIOMET UK LTD. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R