MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK TOTAL KNEE SYSTEM; GMK SPHERIKA FEMORAL COMPONENT S7L CEMENTED

Model Number	02.12.KA07L
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561); Aseptic loosening (4883)
Date of Event	04/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 april 2026 gmk-spherika 02.12.Ka07l gmk spherika femoral component s7l cemented (k211004) lot: 2206208: (b)(4) items manufactured and released on 06-jul-2022.Expiration date: 10-jun-2027.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.E0510fl gmk-sphere tibial insert e-cross - flex 5l - 10mm (k202022) lot: 2248062: (b)(4) items manufactured and released on 03-apr-2023.Expiration date: 14-mar-2028.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.Preliminary investigation based on the information reported in the complaint form approximately two years and nine months following the primary procedure, the patient presented with pain and instability associated with loosening of the femoral component.Upon clinical evaluation, the surgeon noted that a portion of the cement applied during the primary implantation had not achieved complete adhesion.It is not possible to clearly determine whether the issue is related to the bone-cement interface or the implant-cement interface.Suboptimal cementation may be attributable to multiple factors, the majority of which are not related to the device itself.These factors may include, but are not limited to, aspects of the cementation technique, intraoperative temperature conditions, timing of cement application, and the presence of fluids at the cement-implant interface.Based on the available information, it is not possible to conclusively identify the root cause of the complaint.Root cause:aseptic loosening is a known, literature-described adverse event following primary joint arthroplasty, and its causes are often multifactorial and not always clearly identifiable.In this case, loosening of the femoral component may be associated with suboptimal cementation, which can be influenced by several non-device-related factors, including cementation technique, timing of application, intraoperative conditions, and the presence of fluids at the cement interfaces.There is no indication that any potential device-related issue may have caused or contributed to the event, and the investigation does not identify any manufacturing-related issue or systemic deficiency.
Event or Problem Description
At about 2 years and 9 months from the primary, the patient came in presenting pain and instability due to a loose femur.The surgeon observed that some of the cement used to attach the femur in the primary surgery did not adhere completely.The surgeon revised the gmk-spherika s7 femoral component to a gmk-revision s4 femoral component with augments and revised the gmk-spherika 10mm insert to a semiconstrained 12mm insert.The surgery was completed successfully.

• Brand Name: GMK TOTAL KNEE SYSTEM
• Common Device Name: GMK SPHERIKA FEMORAL COMPONENT S7L CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25039774
• Report Number: 3005180920-2026-00362
• Device Sequence Number: 10411054
• Product Code: JWH
• UDI-Device Identifier: 07630345716156
• UDI-Public: 07630345716156
• Combination Product (Y/N): N
• PMA/510(K) Number: K211004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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: 02.12.KA07L
• Device Lot Number: 2206208
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• 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: Male
• Patient Race: Black Or African American