MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/17 MM L

Catalog Number	02.12.0217FL
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	06/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 july 2018; lot 163356: (b)(4) items manufactured and released on 12 september 2016.Expiration date: 29.08.2021.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.Other device involved: gmk-sphere tibial tray fixed cemented size 2 l reference 02.07.1202l (k090988); lot 168496: (b)(4) items manufactured and released on 22 march 2017.Expiration date: 2022-03-13; 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
We were informed on (b)(4) 2018 that the patient came in complaining of instability.The surgeon believes the patient stretched over time.The surgeon plans to revise the poly on (b)(6) 2018.On (b)(6) 2018 we were informed that the surgeon revised the poly and the tibial component on (b)(6).The surgery was completed successfully.

• Brand Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/17 MM L
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7662370
• Report Number: 3005180920-2018-00478
• Device Sequence Number: 16584167
• Product Code: JWH
• UDI-Device Identifier: 07630030826252
• UDI-Public: 07630030826252
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/04/2018

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: 08/29/2021
• Device Catalogue Number: 02.12.0217FL
• Device Lot Number: 163356
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 07/04/2018
• 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