MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 4/14MM

Model Number	02.09.0414H
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	12/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
At 1 month and a half after the surgery, the patient came in reporting pain and stiffness in the knee and the cause of the stiffness is unknown.The surgeon revised gmk-hinge tibial insert - size 4 - 14 with a gmk-hinge tibial insert - size4 - 12 mm.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 15 december 2021: lot 182056: (b)(4) items manufactured and released on 18-june-2018.Expiration date: 2023-05-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 4/14MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13043280
• Report Number: 3005180920-2021-01019
• Device Sequence Number: 12118539
• Product Code: KRO
• UDI-Device Identifier: 07630030825200
• UDI-Public: 07630030825200
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 12/20/2021

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: 05/29/2023
• Device Model Number: 02.09.0414H
• Device Catalogue Number: 02.09.0414H
• Device Lot Number: 182056
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2018
• 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 Sex: Male