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

Catalog Number M5723INT0600220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that clinical study patient had a revision surgery to remove and replace their implant for a late deep wound infection.Review of the device history record indicates that the device was manufactured to specification.All sterilization requirements were met.

Event Description

It was reported that clinical study patient had a revision surgery to remove and replace their implant for a late deep wound infection.

• 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 technology park drive; billerica MA 01821
• Manufacturer Contact: thomas haueter ; 600 technology park drive; billerica, MA 01821 ; 7813459161
• MDR Report Key: 7877634
• MDR Text Key: 120306651
• Report Number: 3004153240-2018-00209
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: M5723INT0600220
• UDI-Public: +M5723INT0600220
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2015
• Device Catalogue Number: M5723INT0600220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2014
• 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: 44 YR