MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE FLEX TIBIAL INSERT SIZE 3 LEFT 10MM; KNEE FIXED PE TIBIAL INSERT

Catalog Number 02.12.0310FL

Device Problems Improper or Incorrect Procedure or Method (2017); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 07/09/2014

Event Type  Injury  

Event Description

Surgeon retrieved patient to theatre for suspected infection.Surgeon was to wash out the knee and perform a liner exchange.In attempting to remove the liner the surgeon did not remove the screw and subsequently the tibial tray was explanted with the liner.

• Brand Name: GMK SPHERE FLEX TIBIAL INSERT SIZE 3 LEFT 10MM
• Type of Device: KNEE FIXED PE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; castel san pietro ; SZ
• MDR Report Key: 4218053
• MDR Text Key: 21245131
• Report Number: 3006639916-2014-00099
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 02.12.0310FL
• Device Lot Number: 140320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/30/2014
• Distributor Facility Aware Date: 07/15/2014
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention