MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 5 / 12 MM; TIBIAL INSERT FIXED

Model Number	02.07.0512FUC
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 10 years and 4 months after the primary surgery, the patient came in reporting instability and the cause of the instability is unknown.The surgeon revised the insert implanting a thicker one.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022.Lot 103790: 49 items manufactured and released on 31-jan-2011.Expiration date: 2015-12-31.No anomalies found related to the problem.To date, 45 items of the same lot have been sold without any similar reported case during the period of review.

• Brand Name: GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 5 / 12 MM
• Common Device Name: TIBIAL INSERT FIXED
• 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: 14839994
• Report Number: 3005180920-2022-00499
• Device Sequence Number: 4793813
• Product Code: JWH
• UDI-Device Identifier: 07630030818295
• UDI-Public: 07630030818295
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• 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): 06/28/2022

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 Expiration Date: 12/31/2015
• Device Model Number: 02.07.0512FUC
• Device Catalogue Number: 02.07.0512FUC
• Device Lot Number: 103790
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2011
• 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
• Patient Race: White