MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERIKA CEMENTLESS; GMK SPHERIKA FEMUR POROUS TIGROWTHC+HA S6L

Model Number	02.12.KA166L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	05/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 jun 2026 gmk-spherika 02.12.Ka166l gmk spherika femur porous tigrowthc+ha s6l (k223548) lot 2505598: (b)(4) items manufactured and released on 11-jun-2025.Expiration date: 26-may-2030.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 2507496: (b)(4) items manufactured and released on 28-apr-2025.Expiration date: 10-apr-2030.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 02.12.3d05l gmk 3dmetal tibial tray size 5l (k221850) lot 2511052: (b)(4) items manufactured and released on 29-jul-2025.Expiration date: 14-jul-2030.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.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
At about 7 months from the primary,the patient presented with pain due to a cyst that had formed on the tibia.The surgeon treated the cyst and revised the size 5l gmk 3d metal tibial tray to a revision tibial tray left size 5.The 10 mm e-cross flex 5l insert was replaced with an insert of the same size, and the porous tigrowthc+ha s6l femoral component was revised to a cemented gmk spherika femoral component size 5l.The surgery was completed successfully.

• Brand Name: GMK SPHERIKA CEMENTLESS
• Common Device Name: GMK SPHERIKA FEMUR POROUS TIGROWTHC+HA S6L
• 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: 25528744
• Report Number: 3005180920-2026-00547
• Device Sequence Number: 9744138
• Product Code: MBH
• UDI-Device Identifier: 07630542702556
• UDI-Public: 07630542702556
• Combination Product (Y/N): N
• PMA/510(K) Number: K223548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 06/17/2026

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.KA166L
• Device Lot Number: 2505598
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2025
• 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 Age: 41 YR
• Patient Sex: Male
• Patient Race: White