BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM ANKLE TIBIAL BASE SIZE 4

    MDR report key: 10909127 · Received November 26, 2020

    Report

    Report Number
    0001822565-2020-03873
    Event Type
    Injury
    Date Received
    November 26, 2020
    Date of Event
    January 24, 2019
    Report Date
    April 8, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSN
    PMA / PMN Number
    K120906
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 · 0

    D11: PROLONG TIBIAL INSERT SZ 4 +2 CAT# 00450005402 LOT# 63655806. TALAR COMPONENT ORANGE SIZE 4 RIGHT CAT# 00450002400 LOT# 63936458. DIST LAT FIB LCK PLATE 6H RT CAT#00-2357-017-06 LOT#NI. P SCR 3 5MMX14MM W/2 7MM HD ST CAT# 00-2348-014-35 LOT#NI - QTY 3. P SCR 3 5MMX16MM W/2 7MM HD ST CAT# 00-2348-016-35 LOT#NI - QTY 2. 3.5MM X 16MM LOCKING SCREW CAT# 00-2359-016-35 LOT#NI. 3.5MM X 18MM LOCKING SCREW CAT# 00-2359-018-35 LOT#NI. 3.5MM X 20MM LOCKING SCREW CAT# 00-2359-020-35 LOT#NI. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2021 - 00009, 0001822565 - 2021 - 00010.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT ANKLE PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT HAS REPORTED ONGOING PAIN AND IMPINGEMENT ISSUES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373041 TM ANKLE TIBIAL BASE SIZE 4 PROSTHESIS, ANKLE HSN ZIMMER BIOMET, INC. NI 64199805

    Patients

    Seq Age Sex Outcome Treatment
    1 Other