BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE PATELLA RESURFACING SIZE 3

    MDR report key: 11884443 · Received May 26, 2021

    Report

    Report Number
    3005180920-2021-00434
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    April 28, 2021
    Report Date
    May 26, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815768
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 10 MAY 2021: LOT 2011821: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JAN-2021. EXPIRATION DATE: 2025-12-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 10 MAY 2021: GMK-SPHERE 02.12.0314FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/14 MM L (K121416) LOT 2005743: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-SEP-2020. EXPIRATION DATE: 2025-08-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATED PATELLA. THE CAUSE OF THE DISLOCATED PATELLA IS UNKNOWN. THE SURGEON PERFORMED AN OSTEOTOMY OF THE TIBIA TO CHANGE TRACKING AND REVISED THE INSERT WITH A 17MM ONE THE DAY AFTER PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS A BIT OF INSTABILITY AND THE SURGEON WANTED TO GIVE THE PATIENT MORE STABILITY SO HE UPSIZED THE POLY AND, INSTEAD OF USING AUGMENTS, THE SURGEON PERFORMED A TIBIAL OSTEOTOMY AND USED HIP SCREWS TO HOLD IT BACK TOGETHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782083 GMK-SPHERE PATELLA RESURFACING SIZE 3 KNEE PATELLA IMPLANT JWH MEDACTA INTERNATIONAL SA 02.07.0035RP 2011821 07630030815768

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention