MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL G2; TOTAL KNEE REPLACEMENT SYSTEM

Catalog Number	RCR-010-0800
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pouch labeled "8mm medial poly insert" and containing the 8mm medial poly insert was contained in the box labeled "lateral b poly insert kit".The correct poly inserts were provided for surgery.Surgery was completed successfully.Review of the device history record indicates that the device was manufactured to specification.Label retains indicate that the correct poly insert pouch and box labels were present.It appears that the labels were applied to the wrong boxes.
Event or Problem Description
The pouch labeled "8mm medial poly insert" and containing the 8mm medial poly insert was contained in the box labeled "lateral b poly insert kit".The correct poly inserts were provided for surgery.Surgery was completed successfully.

• Brand Name: ITOTAL G2
• Common Device Name: TOTAL KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• MDR Report Key: 6572836
• Report Number: 3004153240-2017-00109
• Device Sequence Number: 13592579
• Product Code: JWH
• UDI-Device Identifier: M572RCR0100800031
• UDI-Public: +M572RCR0100800031
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K161366
• 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
• Report Date (Section B): 05/17/2017

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: 10/31/2017
• Device Catalogue Number: RCR-010-0800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2017
• Initial Report FDA Received Date: 05/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR