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

Catalog Number UKA-111-1111

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient is clinically unstable.It was also reported that the 6 mm poly insert originally implanted is too small.A revision surgery is planned to exchange the poly insert.Review of the device history record indicates that the device was manufactured to specification.

Event Description

It was reported that the patient is clinically unstable.It was also reported that the 6 mm poly insert originally implanted is too small.A revision surgery is planned to exchange the poly insert.

• Brand Name: IUNI G2
• Type of Device: UNICONDYLAR KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS.INC.; 600 technology park drive; billerica MA 01821
• Manufacturer (Section G): CONFORMIS, INC.; 600 research drive; wilmington MA 01887
• Manufacturer Contact: karina snow ; 600 technology park drive; billerica, MA 01821 ; 7813459195
• MDR Report Key: 7537637
• MDR Text Key: 109041033
• Report Number: 3004153240-2018-00109
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: M572UKA1111111031
• UDI-Public: +M572UKA1111111031
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: UKA-111-1111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2017
• 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: 45 YR