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

Catalog Number UKA-111-1111

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

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

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that a conformis iuni patient was revised to an off-the-shelf total knee due to tibial loosening.The surgeon presumed it was a cement issue rather than the implant itself.Review of the device history record indicates that the device was manufactured to specification.

Event Description

It was reported that a conformis iuni patient was revised to an off-the-shelf total knee due to tibial loosening.The surgeon presumed it was a cement issue rather than the implant itself.

• 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: paul smolenski ; 600 technology park drive; billerica, MA 01821 ; 7813459161
• MDR Report Key: 8915754
• MDR Text Key: 155059616
• Report Number: 3004153240-2019-00201
• 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: 08/21/2019

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: Health Professional
• Device Catalogue Number: UKA-111-1111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2018
• 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