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

Catalog Number UKA-111-1111

Device Problem Fitting Problem (2183)

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

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

It was reported that the thicker sized poly insert provided with the kit would not fit into the tibial tray.The surgeon used the thinner sized poly insert provided with the kit.Surgery was completed successfully.Review of the device history record indicates the device was manufactured to specification.

Event Description

It was reported that the thicker sized poly insert provided with the kit would not fit into the tibial tray.The surgeon used the thinner sized poly insert provided with the kit.Surgery was completed successfully.

Manufacturer Narrative

It was reported that the thicker sized poly insert provided with the kit would not fit into the tibial tray.The surgeon used the thinner sized poly insert provided with the kit.Surgery was completed successfully.Review of the device history record indicates the device was manufactured to specification.Returned device evaluation: the thicker sized poly insert and additional unused thinner sized poly insert were returned for evaluation.Review indicates that the inserts were manufactured to specification.Some scratches were observed on the thicker poly insert.The posterior and anterior interlocks were undamaged.

• Brand Name: IUNI G2
• 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: 6028302
• MDR Text Key: 57623653
• Report Number: 3004153240-2016-00198
• 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: K092441
• 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: 11/09/2016

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
• Device Operator: Physician
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: UKA-111-1111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2016
• Initial Date FDA Received: 10/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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 Age: 53 YR