BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLONG TIBIAL INSERT SZ 4 +2

    MDR report key: 11139352 · Received January 8, 2021

    Report

    Report Number
    0001822565-2021-00009
    Event Type
    Injury
    Date Received
    January 8, 2021
    Date of Event
    January 24, 2019
    Report Date
    April 8, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSN
    UDI-DI
    00889024269798
    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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: TM ANKLE TIBIAL BASE SIZE 4 CAT# 00450004400 LOT# 64199805; 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. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2021 - 00010, 0001822565-2020-03873.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ANKLE PROCEDURE. SUBSEQUENTLY, THE PATIENT HAS REPORTED 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
    36705 PROLONG TIBIAL INSERT SZ 4 +2 PROSTHESIS, ANKLE HSN ZIMMER BIOMET, INC. NI 63655806 00889024269798

    Patients

    Seq Age Sex Outcome Treatment
    1 Other