MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/23MM

Model Number	02.07.0223SCF
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 december 2021: lot 136398: (b)(4) items manufactured and released on 03-feb-2014.Expiration date: 2018-11-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 1-1-2017.
Event or Problem Description
The patient came in reporting instability and the cause of the instability is unknown.At 5 years and 9 months post implantation the surgeon revised the insert implanting a thicker one and the surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/23MM
• 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: 13058748
• Report Number: 3005180920-2021-01025
• Device Sequence Number: 3887876
• Product Code: JWH
• UDI-Device Identifier: 07630030816970
• UDI-Public: 07630030816970
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• 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): 12/22/2021

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: 11/30/2018
• Device Model Number: 02.07.0223SCF
• Device Catalogue Number: 02.07.0223SCF
• Device Lot Number: 136398
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2014
• 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: Female