MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; FIXED TIBIAL TRAY CEMENTED RIGHT, SIZE 2

Model Number	02.07.1202R
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	04/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 5 months from the primary, the patient came in reporting stiffness.Rehabilitation has been performed in order to restore the joint mobility.
Additional Manufacturer Narrative
Batch review performed on 15-apr-2025: lot 2349049: (b)(4) items manufactured and released on 09-apr-2024.Expiration date: 25-mar-2029.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 15-apr-2025: gmk-spherika 02.12.0210crr tibial insert fixed sphere cr size 2/10 mm r (k181635) lot 2342648: (b)(4) items manufactured and released on 06-dec-2023.Expiration date: 05-nov-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-spherika 02.12.Ka03r femoral component spherika cemented s3r (k211004) lot 2315331: (b)(4) items manufactured and released on 06-sep-2023.Expiration date: 20-aug-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.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.
Additional Manufacturer Narrative
Clinical evaluation: 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.Following a call with the surgeon, he told us 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.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: FIXED TIBIAL TRAY CEMENTED RIGHT, SIZE 2
• 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: 21932364
• Report Number: 3005180920-2025-00369
• Device Sequence Number: 8907397
• Product Code: JWH
• UDI-Device Identifier: 07630030819872
• UDI-Public: 07630030819872
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090988
• 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): 05/28/2025

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: 02.07.1202R
• Device Lot Number: 2349049
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2024
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female