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

Catalog Number	UKA-111-1111
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the 8mm poly insert did not properly sit in the tray during surgery.The 6mm poly insert was implanted to complete the case.Review of the device history record indicates that the device was manufactured to specification.
Event or Problem Description
It was reported that the 8mm poly insert did not properly sit in the tray during surgery.The 6mm poly insert was implanted to complete the case.
Additional Manufacturer Narrative
It was reported that the 8mm poly insert did not properly sit in the tray during surgery.The 6mm poly insert was implanted to complete the case.Review of the device history record indicates that the device was manufactured to specification.Returned device evaluation: the 8mm poly was returned for evaluation.The anterior interlock showed some signs of fraying along the edge, which is typical for an insert that has had the anterior tab engaged with the interlock.It is likely that the anterior tab was engaged somewhat during surgery.Review of the returned insert was inconclusive.

• Brand Name: IUNI G2
• Common Device Name: UNICONDYLAR KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• MDR Report Key: 7008694
• Report Number: 3004153240-2017-00241
• Device Sequence Number: 13624573
• Product Code: HSX
• UDI-Device Identifier: M572UKA1111111031
• UDI-Public: +M572UKA1111111031
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K133256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: UKA-111-1111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR