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

Catalog Number BKA-111-1111

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 08/26/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient had post-op loosening of the tibial baseplate.The patient's knee was revised to an off-the-shelf implant by a non-conformis surgeon.Review of the device history record indicates that the device was manufactured to specification.

Event Description

It was reported that the patient had post-op loosening of the tibial baseplate.The patient's knee was revised to an off-the-shelf implant by a non-conformis surgeon.

• 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: emmanuel nyakako ; 600 technology park drive; billerica, MA 01821 ; 7813459164
• MDR Report Key: 9623864
• MDR Text Key: 176213831
• Report Number: 3004153240-2020-00019
• 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: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• 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: 01/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2018
• 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: 45 YR