MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK TOTAL KNEE SYSTEM; FEMORAL COMPONENT SPHERE SIZE 5+ R TINBN COATED

Model Number	02.12.0725R
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	10/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20-nov-2024: lot 2247645: 18 items manufactured and released on 12-apr-2023.Expiration date: 2028-03-22.No anomalies found related to the problem.To date, 10 items of the same lot have been sold with no similar reported event during the period of review.Additional implants revised, batch review performed on 20-nov-2024: gmk-sphere 02.12.E003rp patella resurfacing size 3 e-cross (k202022) lot 2314117: 55 items manufactured and released on 05-oct-2023.Expiration date: 2028-09-24.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.12.E0511fr tibial insert fixed sphere flex size 5/11 mm r (k202022) lot 2314696: 50 items manufactured and released on 02-aug-2023.Expiration date: 2028-07-15.No anomalies found related to the problem.To date, 26 items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.07.2805r tibial tray fixed cemented size 5 r tinbn coated (k202684) lot 2245298: 24 items manufactured and released on 03-may-2023.Expiration date: 2028-04-15.No anomalies found related to the problem.To date, 16 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.
Event or Problem Description
At about 10 months after primary, the patient came in reporting stiffness and the cause is unknown.The surgeon revised all gmk-sphere components with competitor components.The surgery was completed successfully.

• Brand Name: GMK TOTAL KNEE SYSTEM
• Common Device Name: FEMORAL COMPONENT SPHERE SIZE 5+ R TINBN COATED
• 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: 20756806
• Report Number: 3005180920-2024-00973
• Device Sequence Number: 8561557
• Product Code: JWH
• UDI-Device Identifier: 07630040711593
• UDI-Public: 07630040711593
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K202684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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
• Report Date (Section B): 11/22/2024

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: 02.12.0725R
• Device Lot Number: 2247645
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2023
• 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 Age: 83 YR
• Patient Sex: Male