BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/14 MM L

    MDR report key: 7221025 · Received January 26, 2018

    Report

    Report Number
    3005180920-2018-00005
    Event Type
    Injury
    Date Received
    January 26, 2018
    Date of Event
    December 27, 2017
    Report Date
    January 26, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826214
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 24 JANUARY 2018 LOT 156304: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 APRIL 2016. EXPIRATION DATE: 2021-03-10 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. TIBIAL INSERT FIXED SPHERE FLEX #2/14 MM L REFERENCE 02.12.0214FL (K121416) LOT 163355: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 SEPT 2016. EXPIRATION DATE: 2021-08-30 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO SUPERFICIAL INFECTION AT THE INCISION SITE, THAT COMMUNICATE WITH THE JOINT, 22 DAYS AFTER PRIMARY. THE SURGEON WASHED OUT THE INFECTION AND REPLACED THE POLY WITH A SIZE2X14MMM LEFT POLY. THE SURGEON INSERTED THE POLY INCORRECTLY (LOT 163355), AT WHICH TIME THE LOCKING MECHANISM WAS DAMAGED. AN INSERT FROM ANOTHER LOT WAS OPENED AND INSERTED WITHOUT FURTHER DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64633 TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/14 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 156304 07630030826214

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention