MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 3 / 12 MM; FIXED TIBIAL INSERT

Catalog Number	02.12.0312FL
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	09/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs manager on oct 5, 2018: insert revision in tka 10 months after primary for joint instability.The insert was exchanged to a thicker one.The developmental instability is a rather commonly described possible complication following tka, because soft tissue may stretch and provide insufficient stability.It is therefore common practice to resort to a thicker insert and recreate soft tissue tension.This is not a problem due to any implant defect or malfunction.Batch review performed on 16 october 2018: lot 170292: (b)(4) items manufactured and released on 26 april 2017.Expiration date: 2022-04-06.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 performed due to knee instability after about 1 year from primary.The surgeon revised the 12mm liner to a 14mm liner.
Additional Manufacturer Narrative
On (b)(6) 2018 we were informed that the revision surgery has been successfully performed on (b)(6) 2018.
Event or Problem Description
The surgeon revised the patient 8 months after primary for a knee instability.

• Brand Name: GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 3 / 12 MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7237455
• Report Number: 3005180920-2018-00787
• Device Sequence Number: 1488192
• Product Code: JWH
• UDI-Device Identifier: 07630030826375
• UDI-Public: 07630030826375
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2018

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: 04/06/2022
• Device Catalogue Number: 02.12.0312FL
• Device Lot Number: 170292
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 02/02/2018
• 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: Required Intervention