MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0612FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/12 MM R; KNEE TIBIAL INSERT

Catalog Number	02.12.0612FR
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: insert revision in tka 2 years 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 21 february 2019.Lot 146660: (b)(4) items manufactured and released on 21 january 2015.Expiration date: 2019-12-31.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
Gmk revision performed 2 years after primary surgery, due to instability caused by laxity.The surgeon revised the 12mm poly with a 17mm poly and the surgery was completed successfully.

• Brand Name: GMK-SPHERE 02.12.0612FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/12 MM R
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8357659
• Report Number: 3005180920-2019-00075
• Device Sequence Number: 2229211
• Product Code: JWH
• UDI-Device Identifier: 07630030826986
• UDI-Public: 07630030826986
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2019

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: 12/31/2019
• Device Catalogue Number: 02.12.0612FR
• Device Lot Number: 146660
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 02/21/2019
• 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