BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 20694302 · Received November 15, 2024

    Report

    Report Number
    3005180920-2024-00943
    Event Type
    Injury
    Date Received
    November 15, 2024
    Date of Event
    October 17, 2024
    Report Date
    November 15, 2024
    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 6 NOVEMBER 2024: LOT 2241318: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2023. EXPIRATION DATE: 2027-DEC-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CONCLUSION: THE SURGEON WILL REVISE LINER HEIGHT, WHICH IS A COMMON PRACTICE TO RESTORE THE JOINT MOBILITY. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NOTE: IN SECTION H1 "TYPE OF REPORTABLE EVENT" WE HAVE FLAGGED THE OPTION SERIOUS INJURY. THIS OPTION HAS BEEN INSERTED BECAUSE AT THE MOMENT THE REVISION HAS NOT YET BEEN DONE, BUT IT WILL BE PERFORMED.

    Description of Event or Problem · 0

    THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND EXPRESSED PAIN AND LIGAMENT TIGHTNESS AND THE CAUSE IS UNKNOWN. THE SURGEON IS REQUESTING A 2MM THINNER POLYETHYLENE INSERT AS HE THINKS THE THINNER POLY WOULD PROVIDE BETTER LIGAMENT BALANCE. A REVISION SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307653 GMK SPHERE TOTAL KNEE SYSTEM KNEE TIBIAL INSERT E-CROSS JWH MEDACTA INTERNATIONAL SA 02.12.E0410FR 2241318 07630971261761

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other