MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE FEMORAL COMPONENT CEMENTED - 3+L

Model Number	02.12.0023L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
6 years after the primary surgery, the patient reported stiffness with only a 3° range of motion.The surgeon performed soft tissue releases, downsized the femur by two sizes, and revised the insert (with one of the same size) and patella due to tracking issues.The surgery was completed successfully.No medacta product issue identified.
Additional Manufacturer Narrative
Batch review performed on 31 july 2025.Gmk-sphere 02.12.0023l gmk-sphere femoral component cemented - 3+l (k140826) lot.188920: (b)(4) items manufactured and released on 15 jan 2018.Expiration date: 17 dec 2023.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Additional devices also revised: gmk-sphere 02.12.0310fl gmk-sphere tibial insert - flex s3l - 10 mm (k121416) lot.180372: (b)(4) items manufactured and released on 24 may 2018.Expiration date: 06 may 2023.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.07.0034rp patella resurfacing s.2 (new generation) (k090988) lot.1900601: (b)(4) items manufactured and released on 03 may 2019.Expiration date: 21 april 2024.No anomalies were 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.Conclusions: 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 SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED - 3+L
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 22749124
• Report Number: 3005180920-2025-00782
• Device Sequence Number: 18531252
• Product Code: JWH
• UDI-Device Identifier: 07630030862373
• UDI-Public: 07630030862373
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2025

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: 12/17/2023
• Device Model Number: 02.12.0023L
• Device Lot Number: 188920
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2018
• 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 Age: 58 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Race: White