MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK TOTAL KNEE SYSTEM; GMK-SPHERIKA FEMORAL COMPONENT S4L CEMENTED

Model Number	02.12.KA04L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 october 2025: gmk-spherika 02.12.Ka04l gmk spherika femoral component s4l cemented (k211004) lot 2429610: (b)(4) items manufactured and released on 13-jan-2025.Expiration date: 2029-12-09.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.Gmk-spherika 02.07.1204l tibial tray fixed cemented size 4 l (k090988) lot 2430237: (b)(4) items manufactured and released on 28-feb-2025.Expiration date: 2030-02-12.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.Gmk-spherika 02.12.E0411fl gmk-sphere tibial insert e-cross - flex 4l - 11mm (k202022) lot 2426070: (b)(4) items manufactured and released on 04-nov-2024.Expiration date: 2029-10-16.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 medacta medical affairs director: a revision surgery was performed 4 months after the implantation of a tka, due to joint instability.In the long-leg x-ray, a clear valgus alignment is visible, which resolves in the short field x-ray (probably the long-leg x-rays were taken under weight-bearing or valgus stress).This finding supports the reported instability, indicating medial compartment laxity.Additionally, the tibial component appeared slightly elevated on the medial plateau; however, it is unclear whether this finding developed after weight bearing began or was already present since implantation.
Event or Problem Description
Revision surgery at about 4 months after the primary due to laxity.Tibia, femur, insert revised successfully to semi-contrainted system.
Additional Manufacturer Narrative
D2b wrong product code inserted in the initial mdr: jwl.D2b product code corrected: jwh.

• Brand Name: GMK TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERIKA FEMORAL COMPONENT S4L CEMENTED
• 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: 23437044
• Report Number: 3005180920-2025-01060
• Device Sequence Number: 4695243
• Product Code: JWH
• UDI-Device Identifier: 07630345716095
• UDI-Public: 07630345716095
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K211004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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: 02.12.KA04L
• Device Lot Number: 2429610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2025
• 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: 88 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White