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

Catalog Number UKA-111-1111

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2016

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient has tibial implant loosening.A revision surgery is planned to exchange the tibial tray and poly insert.Review of the device history record indicates the device was manufactured to specification.

Event Description

It was reported that the patient has tibial implant loosening.A revision surgery is planned to exchange the tibial tray and poly insert.

Manufacturer Narrative

It was reported that the patient had tibial implant loosening.The patient was revised to an off the shelf total knee replacement implant system.Review of the device history record indicates the device was manufactured to specification.

Event Description

It was reported that the patient had tibial implant loosening.The patient was revised to an off the shelf total knee replacement implant system.

• Brand Name: IUNI
• 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: 5725589
• MDR Text Key: 47403587
• Report Number: 3004153240-2016-00128
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: UKA-111-1111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2016
• 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: 54 YR