BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM ANKLE PROLONG TIBIAL INSERT SZ 6 +2

    MDR report key: 7780945 · Received August 14, 2018

    Report

    Report Number
    0001822565-2018-03825
    Event Type
    Injury
    Date Received
    August 14, 2018
    Date of Event
    August 3, 2016
    Report Date
    September 4, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSN
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCT: CATALOG #: 00830004600, TIBIAL BASE COMPONENT, LOT # 62239782N CATALOG #: 00830001600, TALAR COMPONENT, LOT # 77004007 REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. IMPLANTS ARE COMPATIBLE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF BIRTH - UNKNOWN DATE, (B)(6). THIS DEVICE IS NOT DISTRIBUTED IN THE USA. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET HAS A SIMILAR DEVICE IN THE UNITED STATES CLEARED UNDER 510K NUMBER K120906. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ANKLE REVISION EIGHT (8) MONTHS POST-IMPLANTATION DUE TO INFECTION. THE PATIENT STARTED HAVING INFECTION SYMPTOMS FIVE (5) MONTHS AFTER INITIAL SURGERY. THE PATIENT UNDERWENT A POLYETHYLENE SWAP AND WASHOUT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623567 TM ANKLE PROLONG TIBIAL INSERT SZ 6 +2 HSN ZIMMER BIOMET, INC. N/A 62621906

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R