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

Model Number	02.12.0026R
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	05/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 may 2026 gmk-sphere 02.12.0026r gmk-sphere femoral component cemented - 6+r (k140826) lot.162695: (b)(4) items manufactured and released on 16-jun-2016.Expiration date: 2021-may-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Gmk-sphere 02.07.1205r tibial tray fix cemented s.5r (k090988) lot.164904: (b)(4) items manufactured and released on 12-oct-2016.Expiration date: 2021-oct-02.No anomalies found related to the problem.To date, all items of the same lot have been sold without any 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
Revision surgery due to aseptic loosening of the knee implants after about 9 years and 4 months from primary.The surgeon revised the gmk-sphere patella s4 to a same size patella, revised the sphere femur cemented right s6 + to a gmk-hinge femoral component size 5, revised the flex right 14mm s5 insert to a gmk-hinge size5 12mm insert, and revised the gmk-sphere tibial cemented tray s5 to a gmk-hinge tibial tray 5r.The surgery was completed successfully.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED - 6+R
• 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: 25297689
• Report Number: 3005180920-2026-00522
• Device Sequence Number: 9249376
• Product Code: JWH
• UDI-Device Identifier: 07630030862441
• UDI-Public: 07630030862441
• Combination Product (Y/N): N
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 05/27/2026

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: 05/24/2021
• Device Model Number: 02.12.0026R
• Device Lot Number: 162695
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2016
• 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: Male
• Patient Race: White