BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L

    MDR report key: 7506732 · Received May 11, 2018

    Report

    Report Number
    3005180920-2018-00324
    Event Type
    Injury
    Date Received
    May 11, 2018
    Date of Event
    April 17, 2018
    Report Date
    June 14, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826139
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PATELLA WAS RIDING LATERAL IN FLEXION. SURGEON RECUT TO THIN OUT BONE AS HE THOUGHT IT WAS THICK. WAS NOT LOOSE BUT SURGEON THOUGHT IS WAS OVERSTUFFED. PATELLA STAYED IN TROCHLEA AFTER RECUT W/ NO SUTURES OR CLAMPS THROUGH OUT RANGE OF MOTION.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11 MAY 2018. LOT 168298: 60 ITEMS MANUFACTURED AND RELEASED ON 16 FEBRUARY 2017. EXPIRATION DATE: 2022-02-01/ NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 48 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED GMK-SPHERE REFERENCE (B)(4) ((B)(4)) PATELLA RESURFACING SIZE 1; LOT 163381: 130 ITEMS MANUFACTURED AND RELEASED ON 07 SEPTEMBER 2016. EXPIRATION DATE: 2021-08-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 116 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2018 WE WERE INFORMED THAT THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON PLANS TO UPSIZE THE POLY ON (B)(6) 2018. ON 17 APRIL 2018 WE WERE INFORMED THAT THE SURGEON UPSIZED THE POLY FROM A 10MM FOR A 17MM. THE SURGEON ALSO REVISED THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350641 TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 168298 07630030826139

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention