MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/10MM; KNEE TIBIAL INSERT

Catalog Number	02.07.0210SCF
Health Effect - Clinical Code	Excessive Tear Production (2235)
Date of Event	11/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018; lot 140467: 30 items manufactured and released on 06 mar 2014; expiration date: 2019-01-31.No anomalies found related to the problem.To date, 24 items of the same lot have been already sold without any similar reported event.Additional implant involved: batch review performed on (b)(6) 2018: gmk-revision 02.07.0682r; revision fixed tibial tray cemented size 2 r (k123721) lot 184299: 11 items manufactured and released on 11-jul-2018; expiration date: 2023-07-03.No anomalies found related to the problem.To date, 3 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in due to an unstable competitor's knee construct.The surgeon revised all competitor hardware with medacta hardware.The surgeon attempted to implant the s2 10mm semi constrained (lot 140467) insert but it would not fit into the tibial tray.The surgeon then subluxed the tibia forward in an effort to insert a second s2 10mm semi constrained insert.When the surgeon subluxed the tibia forward, the lcl tendon tore away bone from the femur.The lcl tendon was then screwed into place and the surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/10MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8137080
• Report Number: 3005180920-2018-00975
• Device Sequence Number: 194937
• Product Code: JWH
• UDI-Device Identifier: 07630030816499
• UDI-Public: 07630030816499
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 02.07.0210SCF
• Device Lot Number: 140467
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 12/06/2018
• 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: Other