MAUDE Adverse Event Report: Medacta International SA GMK Primary Total Knee System; GMK Tibial Tray Cemented Right S2

Model Number	02.07.1202R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	07/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery after 2 years and 8 months from the primary due to pain.The surgeon revised the tibial tray, insert, femoral component, and patella from gmk-sphere to gmk-revision.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 04 august 2026 01.29.209 mectacer head biolox delta dia.36 12/14-m (k112115) lot.2525890: (b)(4) items manufactured and released on 21 october 2025.Expiration date: 05 october 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.02.12.E0210fr tibial insert fixed sphere flex size2/10 mm r e-cross (k202022) lot.2317655: 89 items manufactured and released on 08 august 2023.Expiration date: 15 july 2028.No anomalies reported.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.02.12.0003r sphere femur cemented right s3 (k121416) lot.2246796: (b)(4) items manufactured and released on 28 february 2023.Expiration date: 10 february 2028.No anomalies reported.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.02.12.E001rp patella resurfacing size 1 e-cross (k202022) lot.2310246: (b)(4) items manufactured and released on 05 september 2023.Expiration date: 20 august 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.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.

• Brand Name: GMK Primary Total Knee System
• Common Device Name: GMK Tibial Tray Cemented Right S2
• 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: 50232825
• Report Number: 3005180920-2026-00844
• Device Sequence Number: 10546488
• Product Code: JWH
• UDI-Device Identifier: 07630030819872
• UDI-Public: 07630030819872
• Combination Product (Y/N): N
• PMA/510(K) Number: K090988
• 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
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

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: 02.07.1202R
• Device Lot Number: 2311036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2023
• 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: Female