MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 3/12MM; KNEE REVISION INSERT PE

Model Number	02.09.0312H
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At 1 week from primary surgery the surgeon found the hinge mechanism loose, hinge pivot inside the liner, femur detached from pivot and screw free in the joint.He did open the knee, inserted the femur in the pivot and re-tightened the post locking screw (the one loose in the joint) completing the surgery successfully.The post screw was not screwed during the primary due to user error.
Additional Manufacturer Narrative
Batch review performed on 28 june 2022 lot 2114867: (b)(4) items manufactured and released on 12-jan-2022.Expiration date: 2026-12-12.No anomalies found related to the problem.To date, 3 items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 3/12MM
• Common Device Name: KNEE REVISION INSERT PE
• 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: 15041335
• Report Number: 3005180920-2022-00543
• Device Sequence Number: 6943343
• Product Code: KRO
• UDI-Device Identifier: 07630030825125
• UDI-Public: 07630030825125
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2022

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: 02.09.0312H
• Device Catalogue Number: 02.09.0312H
• Device Lot Number: 2114867
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2022
• 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: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White