BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILITY TIBIAL SHELL SZ 5 LT

    MDR report key: 11358413 · Received February 22, 2021

    Report

    Report Number
    1818910-2021-03529
    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
    Removal / Correction Number
    IN
    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 (B)(6) 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

    USA 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
    258679 AGILITY TIBIAL SHELL SZ 5 LT AGILITY ANKLE SYSTEM IMPLANT : ANKLE TIBIAL OYK DEPUY ORTHOPAEDICS INC US W4AFL1002

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention AGILITY POST AUG TALAR SZ 5| AGILITY TIBIAL +2 INSERT SZ 5| UNK MANUFACTURER SCREW| UNK MANUFACTURER SCREW