MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE FEMORAL COMPONENT CEMENTED - 2+L

Model Number	02.12.0022L
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	04/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 may 2026 gmk-sphere 02.12.0022l gmk-sphere femoral component cemented - 2+l (k140826) lot 2308888: (b)(4) items manufactured and released on 12/jul/2023.Expiration date: 24/06/2028.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.Gmk-sphere 02.12.E0213fl gmk-sphere tibial insert e-cross - flex 2l - 13mm (k202022) lot 2242207: 30 items manufactured and released on 03/jan/2023.Expiration date: 05/dec/2027.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.
Event or Problem Description
At about 6 months from primary, the patient came in presenting pain and instability that was determined to be due to the primary femoral component not being externally rotated adequately, which was causing pain along the patella tendon.The surgeon observed that the joint was a couple of degrees of recurvatum.The surgeon revised the 13mm insert to a semiconstrained 23mm insert, revised the s2+ femur to a rev.P.S.Cemented s3 femur, and resurfaced the patient`s natural patella.The surgery was completed successfully.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED - 2+L
• 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: 25160334
• Report Number: 3005180920-2026-00452
• Device Sequence Number: 10642552
• Product Code: JWH
• UDI-Device Identifier: 07630030862472
• UDI-Public: 07630030862472
• Combination Product (Y/N): N
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 05/13/2026

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: 02.12.0022L
• Device Lot Number: 2308888
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/13/2026
• 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
• Patient Race: White