MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; GMK-SPHERIKA 02.07.0034RP PATELLA RESURFACING SIZE 2

Model Number	02.07.0034RP
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
Additional Manufacturer Narrative
Batch review performed on 15-apr-2025.Lot 2416833: (b)(4) items manufactured and released on 07-aug-2024.Expiration date: 24-jul-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.Other devices involved: gmk-spherika 02.12.0410crr tibial insert fixed sphere cr size 4/10 mm r (k181635) lot 2409768: (b)(4) items manufactured and released on 28-may-2024.Expiration date: 15-may-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.Gmk-spherika 02.12.Ka04r femoral component spherika cemented s4r (k211004) lot 2347597: (b)(4) items manufactured and released on 29-apr-2024.Expiration date: 11-apr-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.Gmk-spherika 02.12.T3i4r tibial tray fixed cemented # t3i4 r (k121416) lot 2341924: (b)(4) items manufactured and released on 04-mar-2024.Expiration date: 18-feb-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.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
The patient came in reporting stiffness at about 5 months after the primary.Rehabilitation has been performed in order to restore the joint mobility.
Additional Manufacturer Narrative
Clinical evaluation performed by clinical 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.Edited fields: h11, added clinical evaluation.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERIKA 02.07.0034RP PATELLA RESURFACING 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: 21933168
• Report Number: 3005180920-2025-00368
• Device Sequence Number: 8714697
• Product Code: JWH
• UDI-Device Identifier: 07630030815751
• UDI-Public: 07630030815751
• 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): 05/19/2025

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: 02.07.0034RP
• Device Lot Number: 2416833
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2024
• 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: 50 YR
• Patient Sex: Female