BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM ANKLE TIBIAL INSERT COMPONENT SIZE 4

    MDR report key: 7769509 · Received August 9, 2018

    Report

    Report Number
    0001822565-2018-03817
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    October 20, 2016
    Report Date
    November 30, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    ITW
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF BIRTH - UNKNOWN DATE, (B)(6). REPORT SOURCE FOREIGN: THE EVENT OCCURRED IN (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. MULTIPLE MDR'S WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT(S): 0001822565 -2018 -03816. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. EXAMINATION OF THE REPORTED DEVICE(S) WAS NOT POSSIBLE AS IT WAS NOT RETURNED. REVIEW OF DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. X-RAY REVIEW CONFIRMS THE ARTHROSIS OF THE ANKLE JOINT AND TIBIAL LOOSENING. THE INVESTIGATION CAN DRAW NO FURTHER CONCLUSIONS WITH THE INFORMATION MADE AVAILABLE. ROOT CAUSE IS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS IDENTIFIED 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

    PATIENT UNDERWENT ANKLE ARTHROPLASTY REVISION TO ADDRESS PROGRESSIVE VALGUS MALALIGNMENT AND SUBSEQUENT INSTABILITY. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609713 TM ANKLE TIBIAL INSERT COMPONENT SIZE 4 PROSTHESIS, EXTREMITY ITW ZIMMER BIOMET, INC. N/A 62998292

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R 00830001400 TALAR COMPONENT, LOT 62990950