BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R E-CROSS

    MDR report key: 17754051 · Received September 15, 2023

    Report

    Report Number
    3005180920-2023-00733
    Event Type
    Injury
    Date Received
    September 15, 2023
    Date of Event
    August 21, 2023
    Report Date
    September 15, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261761
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 01 SEPTEMBER 2023: LOT 2241318: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3-JAN-2023. EXPIRATION DATE: 2027-12-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED BY THE SURGEON THAT THE PATIENT'S KNEE IS VERY TIGHT. AFTER FURTHER DISCUSSION, IT WAS CONCLUDED THAT A CUSTOM SIZE (THINNER) POLY IMPLANT WOULD BE NEEDED FOR THE PATIENT. A REVISION HAS NOT BEEN SCHEDULED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686451 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R E-CROSS KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2241318 07630971261761

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention