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

Catalog Number	UKA-111-1111
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the surgeon didn't feel like the size femoral component covered the condyle of the femur enough.There was articular cartilage that showed wear superior to the top of the implant.They felt that the implant should have extended high enough to cover that area.Patient was converted intraoperatively to a ots total knee.The case was completed successfully.Review of the device history record indicates that device was manufactured to specification.
Event or Problem Description
It was reported that the surgeon didn't feel like the size femoral component covered the condyle of the femur enough.There was articular cartilage that showed wear superior to the top of the implant.They felt that the implant should have extended high enough to cover that area.Patient was converted intraoperatively to a ots total knee.The case was completed successfully.
Additional Manufacturer Narrative
It was originally reported that the patient has slippage and loose or dislocated poly insert.A revision surgery occurred to exchange the poly insert.Following revision surgery, it was reported that there was no loose or dislocated poly insert.It was reported that cement leak out medially after the initial surgery and was cleaned up by the surgeon.Review of the device history record indicates that the device was manufactured to specification.
Event or Problem Description
It was originally reported that the patient has slippage and loose or dislocated poly insert.A revision surgery occurred to exchange the poly insert.Following revision surgery, it was reported that there was no loose or dislocated poly insert.It was reported that cement leak out medially after the initial surgery and was cleaned up by the surgeon.

• Brand Name: IUNI
• Common Device Name: UNICONDYLAR KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• MDR Report Key: 7222949
• Report Number: 3004153240-2018-00272
• Device Sequence Number: 1691662
• Product Code: HSX
• UDI-Device Identifier: M572UKA1111111031
• UDI-Public: +M572UKA1111111031
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K133256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: UKA-111-1111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 01/26/2018
• Supplement Report FDA Received Date: 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR