MAUDE Adverse Event Report: CONFORMIS, INC. IDUO G2; BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM

Catalog Number	BKA-111-1111
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient has an infection.A revision surgery is planned to exchange the poly insert.Review of the device history record indicates that the device was manufactured to specification.All sterilization requirements were met.
Event or Problem Description
It was reported that the patient has an infection.A revision surgery is planned to exchange the poly insert.

• Brand Name: IDUO G2
• Common Device Name: BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 28 crosby dr.; bedford MA 01730
• MDR Report Key: 6346091
• Report Number: 3004153240-2017-00044
• Device Sequence Number: 984741
• Product Code: NPJ
• UDI-Device Identifier: M572BKA1111111021
• UDI-Public: +M572BKA1111111021
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K093513
• 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
• Report Date (Section B): 02/21/2017

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: Physician
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: BKA-111-1111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2017
• Initial Report FDA Received Date: 02/21/2017
• 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: 51 YR