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

Catalog Number	UKA-111-1111
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the 8 mm poly insert would not engage on posterior lip.The 6 mm 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 8 mm poly insert would not engage on posterior lip.The 6 mm poly insert was implanted to complete the case.
Additional Manufacturer Narrative
It was reported that the 8mm poly insert would not engage on posterior lip.The first 6mm poly insert was attempted with the same results.The second 6mm poly provide with the kit 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 and 6 mm sized poly inserts were returned for evaluation.Review indicates that the inserts were manufactured to specification.The inserts showed clear marks of the posterior edge of the tray about 5mm inbound of the edge of the poly.Observation suggest that the insert was likely resting on the top of the posterior tray rather than engaged with the posterior interlock while impacting.The anterior interlock is also deformed in a way that would suggest the poly was not sitting flush with the tray with the posterior interlock engaged when the insert was impacted.
Event or Problem Description
It was reported that the 8mm poly insert would not engage on posterior lip.The first 6mm poly insert was attempted with the same results.The second 6mm poly provide with the kit was implanted to complete the case.

• Brand Name: IUNI G2
• Common Device Name: UNICONDYLAR KNEE REPLACEMEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC; 600 technology park drive; billerica MA 01821
• MDR Report Key: 7148614
• Report Number: 3004153240-2017-00281
• Device Sequence Number: 1276792
• 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
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2018

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: 05/31/2018
• Device Catalogue Number: UKA-111-1111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR