MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; PATELLA RESURFACING S.3 (NEW GENERATION)

Model Number	02.07.0035RP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 february 2026: gmk-sphere 02.07.0035rp patella resurfacing s.3 (new generation) (k090988) lot 189226: (b)(4) items manufactured and released on 18-dec-2018.Expiration date: 2023-dec-18.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-sphere 02.07.1204r tibial tray fix cemented s.4r (k090988) lot 184963: (b)(4) items manufactured and released on 31-oct-2018.Expiration date: 2023-oct-21.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.12.0005r gmk-sphere femoral component cemented - 5r (k121416) lot 180968: (b)(4) items manufactured and released on 30-may-2018.Expiration date: 2023-may-17.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-sphere 02.12.0413fr gmk-sphere tibial insert - flex s4r - 13 mm (k140826) lot 179697: (b)(4) items manufactured and released on 24-apr-2018.Expiration date: 2023-apr-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one 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
The patient had knee instability and the cause is unknown.At about 6 years and 11 months post primary the surgeon revised the patella from a size 3 to a size 4, the tibial tray from a size 4 to a size 6, the gmk-sphere femur size 5 to a gmk-spherika femur size 5, and the insert from a 13mm size 4 to a 12mm size 6 to increase stability.The surgery was completed successfully.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: PATELLA RESURFACING S.3 (NEW GENERATION)
• 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: 24558204
• Report Number: 3005180920-2026-00195
• Device Sequence Number: 9330723
• Product Code: JWH
• UDI-Device Identifier: 07630030815768
• UDI-Public: 07630030815768
• Combination Product (Y/N): N
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 03/10/2026

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 Expiration Date: 12/03/2023
• Device Model Number: 02.07.0035RP
• Device Lot Number: 189226
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2018
• 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