MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM R

Model Number	02.12.0414FR
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 may 2025.(b)(4) items manufactured and released on 16-apr-2014.Expiration date: 2019-02-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Clinical evaluation performed by clinical affairs department.8.5 years after primary cemented tka, the insert fixation screw is found loose and surgery is undertaken to remove the loose screw (not broken) and exchange the tibial insert.The metal components were soundly in place and working well.Self-unscrewing of the insert screw is an adverse event already reported for the gmk baseplate, though it's altogether exceptional that the issue is detected after such a long time.The introduction of the torque-limiting screwdriver took place after this primary operation, and therefore this device was not used - it has been observed that the introduction of this measure reduced the number of cases to practically zero.It is therefore legitimate to suppose that insufficient torque had been applied at the time of index surgery, although the length of time is an anomalous parameter.However, no radiological history has been supplied, hence we cannot determine when the event took place.Root cause: the most likely reason for this event is insufficient torque applied to the screw at index surgery.However, other factors may also have played a role, but no determination can be made based on the information available.The investigation does not indicate any potential manufacturing related issue or systemic deficiency.Additional devices involved: gmk-sphere 02.12.T3i4r tibial tray fixed cemented size t3i4 r (k121416) lot.163352 (b)(4) items manufactured and released on 08-aug-2016.Expiration date: 2021-07-24.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.
Event or Problem Description
At about 8 years and 6 months after the primary surgery, the patient came in reporting pain and an x-ray revealed that the screw had backed out of the poly.The reason for the loose tibia and the loose screw is unknown.The surgeon revised the tibia and insert.The surgery was completed successfully.The torque limiter was not used during primary surgery.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM R
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 22269562
• Report Number: 3005180920-2025-00558
• Device Sequence Number: 19768514
• Product Code: JWH
• UDI-Device Identifier: 07630030826627
• UDI-Public: 07630030826627
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 02.12.0414FR
• Device Lot Number: 141031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown