MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK TOTAL KNEE SYSTEM; FEMORAL COMPONENT SPHERIKA CEMENTED S5R

Model Number	02.12.KA05R
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	01/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 03-03-2025: lot 2401766: (b)(4) items manufactured and released on 24-07-2024.Expiration date: 2029-07-03.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.Additional implants involved; batch review performed on 03-03-2025: gmk-spherika 02.07.1204r tibial tray fixed cemented size 4 r (k090988) lot 2416662: (b)(4) items manufactured and released on 30-09-2024.Expiration date: 2029-09-12.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-spherika 02.12.E0410fr tibial insert fixed sphere flex size 4/10 mm r e-cross (k202022) lot 2414989: (b)(4) items manufactured and released on 24-07-2024.Expiration date: 2029-07-10.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.The development of stiffness of the joint is a rather commonly described possible complication following tka, surgeon decided to treat the patient with knee manipulation.There is no indication that any potential issue with the device may have caused or contributed to the event.
Event or Problem Description
Adverse event during clinical study.At about 1 month and a half from primary surgery, the surgeon treated the patient for rigidity and stiffness of the knee under anesthesia.
Additional Manufacturer Narrative
Clincal evaluation performed by clincal affairs department: few months after primary tka, stiffness is felt by the patient and mobilization under anesthesia is carried out.According to the surgeon, this treatment solved the problem.The surgeon himself said that this is a type of situation that occasionally presents itself after tka, and he thinks there is no relation whatsoever with the device implanted.Information reported in this follow up: - clinical evaluation in the section h11.

• Brand Name: GMK TOTAL KNEE SYSTEM
• Common Device Name: FEMORAL COMPONENT SPHERIKA CEMENTED S5R
• 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: 21618032
• Report Number: 3005180920-2025-00234
• Device Sequence Number: 20516788
• Product Code: JWH
• UDI-Device Identifier: 07630345716125
• UDI-Public: 07630345716125
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K211004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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 Model Number: 02.12.KA05R
• Device Lot Number: 2401766
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2024
• 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: Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 98 KG