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

Catalog Number UKA-111-1111

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient has extraneous bone cement in the joint.A procedure is planned to remove the extraneous bone cement arthroscopically.A procedure to open the knee and remove the poly insert to extricate the cement may be required.Review of the device history record indicates that the device was manufactured to specification.

Event Description

It was reported that the patient has extraneous bone cement in the joint.A procedure is planned to remove the extraneous bone cement arthroscopically.A procedure to open the knee and remove the poly insert to extricate the cement may be required.

• 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 dr.; wilmington MA 01887
• Manufacturer Contact: karina snow ; 600 technology park drive; billerica, MA 01821 ; 7813459195
• MDR Report Key: 6860991
• MDR Text Key: 85906921
• Report Number: 3004153240-2017-00195
• 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: 09/13/2017

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: 05/31/2017
• 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
• Initial Date Manufacturer Received: 08/18/2017
• Initial Date FDA Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2016
• 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: 56 YR