BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILITY TIBIAL INSERT SZ 5

    MDR report key: 11365535 · Received February 23, 2021

    Report

    Report Number
    1818910-2021-03630
    Event Type
    Injury
    Date Received
    February 23, 2021
    Date of Event
    April 30, 2008
    Report Date
    February 8, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    OYK
    UDI-DI
    10603295058755
    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

    (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. (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

    ON (B)(6) 2003, THE PATIENT UNDERWENT A PRIMARY LEFT TOTAL ANKLE REPLACEMENT. DEPUY PRODUCTS WERE IMPLANTED ALONG WITH TWO UNKNOWN MANUFACTURER SCREWS. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2008, THE PATIENT UNDERWENT A LEFT ANKLE POLY REVISION/EXCHANGE AND DEBRIDEMENT TO ADDRESS POLY WEAR, CYSTS, PAIN, NUMBNESS, INFLAMMATION, SWELLING, ADHESIONS, AND INFECTION. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS LEADING UP TO THE REVISION OPERATION. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2003. DOR: (B)(6) 2008; LEFT ANKLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266202 AGILITY TIBIAL INSERT SZ 5 AGILITY ANKLE SYSTEM IMPLANT : ANKLE TIBIAL OYK DEPUY ORTHOPAEDICS INC US 1555-35-000 W34BV1009 10603295058755

    Patients

    Seq Age Sex Outcome Treatment
    1 53 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