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

Catalog Number BKA-111-1111

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that the surgeon implanted the femoral component, but was not comfortable with the tibial resection for the tibial implant.He converted to an off-the-shelf implant to complete the surgery successfully.Review of the device history record indicates that the device was manufactured to specification.

Event Description

It was reported that the surgeon implanted the femoral component, but was not comfortable with the tibial resection for the tibial implant.He converted to an off-the-shelf implant to complete the surgery successfully.

• Brand Name: IDUO G2
• Type of Device: BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• Manufacturer (Section G): CONFORMIS, INC.; 600 research drive; wilmington MA 01887
• Manufacturer Contact: paul smolenski ; 600 technology park drive; billerica, MA 01821 ; 7813459093
• MDR Report Key: 9109560
• MDR Text Key: 162814089
• Report Number: 3004153240-2019-00232
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: M572BKA1111111021
• UDI-Public: +M572BKA1111111021
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BKA-111-1111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 76 YR