MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/20MM; KNEE TIBIAL INSERT

Catalog Number	02.07.0320SCF
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 08 november 2018: lot 140476: (b)(4) items manufactured and released on 06-jun-2014.Expiration date: 2019-04-30.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
The tibial insert (22mm) would not snap into the tibial tray.The surgeon ended up dropping to a 17mm insert and that worked.
Additional Manufacturer Narrative
Visual inspection of the uhmwpe semi-constrained revision insert: some dents and scratches can be noted on the distal surface of the insert.The posterior features of the 'snapping' mechanism have been plastically deformed and damaged, especially in one side.They both present a sort of incision with the negative shape of the clipping "tooth" of the baseplate.We can suppose that, in the first attempt to fix the insert into the baseplate, the insert was posteriorly not well positioned (we can suppose that the insertion was difficult because the joint was tight using a 20mm thick insert; that's the reason why was then used a 17mm insert).In this attempt the insert was pushed posteriorily and was permanently damaged without possibility to be clipped in the following attempts.We can state that the event is not implant related.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/20MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8050711
• Report Number: 3005180920-2018-00878
• Device Sequence Number: 19322675
• Product Code: JWH
• UDI-Device Identifier: 07630030817519
• UDI-Public: 07630030817519
• 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,Followup
• Report Date (Section B): 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 02.07.0320SCF
• Device Lot Number: 140476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Outcome Attributed to Adverse Event: Other