MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE 1/14 MM L

Catalog Number	02.12.0114FL
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	09/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 september 2018; lot 172585: (b)(4) items manufactured and released on 24 february 2014.Expiration date: 2019-01-31; 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
Information received on aug 28, 2018: the patient came in complaining of instability 1 year and 6 months after primary.The surgeon plans to revise the patient on (b)(6) 2018.More information to follow the case.Update (b)(6) 2018 : the liner was revised.The liner implanted during the revision is 02.12.0120fl sphere insert flex left 20mm s1 154729.The surgery was completed successfully.

• Brand Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 1/14 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: 7905422
• Report Number: 3005180920-2018-00723
• Device Sequence Number: 19246057
• Product Code: JWH
• UDI-Device Identifier: 07630030826016
• UDI-Public: 07630030826016
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2018

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: 01/31/2019
• Device Catalogue Number: 02.12.0114FL
• Device Lot Number: 135729
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/25/2018
• 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