BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILITY POST AUG TALAR SZ 5

    MDR report key: 11358402 · Received February 22, 2021

    Report

    Report Number
    1818910-2021-03528
    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
    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. H10 ADDITIONAL NARRATIVE: ADDED: B1 (IS PRODUCT PROBLEM)

    Additional Manufacturer Narrative · 1

    (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 22 JAN 2021. DOI: UNKNOWN, DOR: UNKNOWN, UNKNOWN AFFECTED SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258341 AGILITY POST AUG TALAR SZ 5 AGILITY ANKLE SYSTEM IMPLANT : ANKLE TALAR OYK DEPUY ORTHOPAEDICS INC US W32BL1009

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention AGILITY TIBIAL +2 INSERT SZ 5| AGILITY TIBIAL SHELL SZ 5 LT| UNK MANUFACTURER SCREW| UNK MANUFACTURER SCREW| AGILITY TIBIAL +2 INSERT SZ 5.| AGILITY TIBIAL SHELL SZ 5 LT.| UNK MANUFACTURER SCREW.| UNK MANUFACTURER SCREW.