MAUDE Adverse Event Report: CONFORMIS, INC. IUNI G2; UNICONDYLAR KNEE REPLACEMENT SYSTEM

Catalog Number M5722INT0600220

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient has pain.X-rays indicate a shadow in the tibial area.A revision surgery is planned to exchange the poly insert.Review of the device history record indicates the device was manufactured to specification.

Event Description

It was reported that the patient has pain.X-rays indicate a shadow in the tibial area.A revision surgery is planned to exchange the poly insert.

Manufacturer Narrative

It was originally reported that the patient had pain.X-rays indicated a shadow in the tibial area.A revision surgery occurred.At the time of revision surgery, the poly insert was observed to be fixed in the tibial tray.The poly insert showed wear and a slight yellow discoloration.The poly insert was exchanged during the procedure.Review of the device history record indicates that the device was manufactured to specification.

Event Description

It was originally reported that the patient had pain.X-rays indicated a shadow in the tibial area.A revision surgery occurred.At the time of revision surgery, the poly insert was observed to be fixed in the tibial tray.The poly insert showed wear and a slight yellow discoloration.The poly insert was exchanged during the procedure.

Manufacturer Narrative

It was originally reported that the patient had pain.X-rays indicated a shadow in the tibial area.A revision surgery occurred.At the time of revision surgery, the poly insert was observed to be fixed in the tibial tray.The poly insert showed wear and a slight yellow discoloration.The poly insert was exchanged during the procedure.Review of the device history record indicates that the device was manufactured to specification.Device evaluation: the retrieved poly insert was returned for evaluation.Approximate wear measurements were taken from the contact zone on the articular surface of the insert.Amount of wear does not appear to be abnormal.The yellow discoloration was removed during disinfection.

• Brand Name: IUNI G2
• Type of Device: UNICONDYLAR KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 28 crosby dr.; bedford MA 01730
• Manufacturer (Section G): CONFORMIS, INC.; 600 research dr.; wilmington MA 01887
• Manufacturer Contact: karina snow ; 28 crosby dr.; bedford, MA 01730 ; 7813459195
• MDR Report Key: 5971637
• MDR Text Key: 55422554
• Report Number: 3004153240-2016-00187
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K111916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2017

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
• Device Operator: Physician
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: M5722INT0600220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2016
• Initial Date FDA Received: 09/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/30/2016; 01/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 MO