MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE FEMORAL COMPONENT CEMENTED - 6R

Model Number	02.12.0006R
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 may 2026 gmk-sphere 02.12.0006r gmk-sphere femoral component cemented - 6r (k121416) lot 2012023: (b)(4) items manufactured and released on 15-jan-2021.Expiration date: 2025-12-27.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Gmk-sphere 02.12.0510crr tibial insert fixed sphere cr size 5/10 mm r (k181635) lot 2009877: (b)(4) items manufactured and released on 17-nov-2020.Expiration date: 2025-11-02.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-sphere 02.07.1205r tibial tray fix cemented s.5r (k090988) lot 2009495: (b)(4) items manufactured and released on 02-dec-2020.Expiration date: 2025-11-23.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Gmk-sphere 02.07.0036rp resurfacing patella size 4 (k113571) lot 2011091: (b)(4) items manufactured and released on 18-march-2021.Expiration date: 2025-11-08.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.Root cause: infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.
Event or Problem Description
At about 5 years 1 month after the primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon removed all medacta implants and implanted antibiotic spacers.The surgery was completed successfully.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED - 6R
• 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: 25442545
• Report Number: 3005180920-2026-00539
• Device Sequence Number: 5727575
• Product Code: JWH
• UDI-Device Identifier: 07630030825880
• UDI-Public: 07630030825880
• Combination Product (Y/N): N
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 06/09/2026

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: 12/27/2025
• Device Model Number: 02.12.0006R
• Device Lot Number: 2012023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2021
• 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