MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 1/10MM; KNEE TIBIAL INSERT FIXED

Catalog Number	02.07.0110SCF
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 february 2019: lot 134125: (b)(4) items manufactured and released on 06-dec-2013.Expiration date: 2018-10-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery after 1 year and 3 months from the primary due to instability.The patient was stable during extension medially and laterally but was subluxing with anterior flexion.The 10mm liner has been revised with a 14mm liner and the surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 1/10MM
• Common Device Name: KNEE TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8377328
• Report Number: 3005180920-2019-00110
• Device Sequence Number: 240391
• Product Code: JWH
• UDI-Device Identifier: 07630030815911
• UDI-Public: 07630030815911
• 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: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2019

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: No Information
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 02.07.0110SCF
• Device Lot Number: 134125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention