BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILITY TIBIAL +2 INSERT SZ 5

    MDR report key: 11358408 · Received February 22, 2021

    Report

    Report Number
    1818910-2021-03530
    Event Type
    Injury
    Date Received
    February 22, 2021
    Date of Event
    November 14, 2018
    Report Date
    February 8, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    OYK
    UDI-DI
    10603295058779
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT CODE/LOT NUMBER COMBINATION SINCE 01-JAN-2015. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEVICE HISTORY LOT : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). WHERE THE LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    MEDICAL RECORDS WERE RECEIVED ON (B)(6) 2021. DOI: UNKNOWN, DOR: UNKNOWN, UNKNOWN AFFECTED SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258680 AGILITY TIBIAL +2 INSERT SZ 5 AGILITY ANKLE SYSTEM IMPLANT : ANKLE TIBIAL OYK DEPUY ORTHOPAEDICS INC US 1555-35-020 X5EJ51 10603295058779

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention AGILITY POST AUG TALAR SZ 5| AGILITY TIBIAL SHELL SZ 5 LT| UNK MANUFACTURER SCREW| UNK MANUFACTURER SCREW| AGILITY POST AUG TALAR SZ 5| AGILITY TIBIAL SHELL SZ 5 LT| UNK MANUFACTURER SCREW| UNK MANUFACTURER SCREW