MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; GMK-SPHERIKA TIBIAL TRAY FIX CEMENTED S.3R

Model Number	02.07.1203R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 september 2025: gmk-spherika 02.07.1203r tibial tray fix cemented s.3r (k090988) lot: 2409571: (b)(4) items manufactured and released on 05-aug-2024.Expiration date: 18-jul-2029.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Gmk-spherika 02.12.E0310fr gmk-sphere tibial insert e-cross - flex 3r - 10mm (k202022) lot: 2406195: (b)(4) items manufactured and released on 12-apr-2024.Expiration date: 19-mar-2029.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Gmk-spherika 02.12.Ka12r gmk spherika femoral component s2+r cemented (k211004) lot: 2413824: (b)(4) items manufactured and released on 05-sep-2024.Expiration date: 21-aug-2029.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.Clinical evaluation performed by medacta medical affaris manager: a revision surgery was performed one year after the implantation of a total knee arthroplasty (tka) due to flexion instability.This type of postoperative instability is a relatively common complication following tka, as soft tissues may stretch over time and fail to provide adequate stability.In some cases, the issue may arise from suboptimal component selection or malpositioning; however, in this case, the available x-ray images showed satisfactory component alignment and positioning.The revision procedure involved replacing the prosthesis with a hinged design, as the use of a thicker insert was deemed insufficient to restore stability.The problem does not appear to be related to any implant defect or malfunction.The surgeon revised liner height, which is a common practice to restore the joint stability.There is no indication that any potential issue with the device may have caused or contributed to the event.
Event or Problem Description
Almost 1 year after the primary surgery, the patient came in due to flexion imbalance and the cause is unknown.The surgeon determined that a flexion imbalance wouldn't be corrected by a poly swap or upsizing, so about 11 months after the primary surgery, he revised to a hinge system to increase stability.The surgery was completed successfully.Pcl (posterior cruciate ligament) was sacrificed at the primary surgery and the surgeon thinks that this caused the flexion imbalance.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERIKA TIBIAL TRAY FIX CEMENTED S.3R
• 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: 23310527
• Report Number: 3005180920-2025-01019
• Device Sequence Number: 14699687
• Product Code: JWH
• UDI-Device Identifier: 07630030819896
• UDI-Public: 07630030819896
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 10/16/2025

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 Model Number: 02.07.1203R
• Device Lot Number: 2409571
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2024
• 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