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

Catalog Number M5723INT0600220

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient has a low grade infection.The patient got an iduo implanted, initially without a patella replacement.A patella component was then subsequently implanted in another hospital.Thereafter, again in another hospital, a pain mobilization was performed.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 the patient has a low grade infection.The patient got an iduo implanted, initially without a patella replacement.A patella component was then subsequently implanted in another hospital.Thereafter, again in another hospital, a pain mobilization was performed.

• 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: thomas haueter ; 600 technology park drive; billerica, MA 01821 ; 7813459161
• MDR Report Key: 8237755
• MDR Text Key: 132762907
• Report Number: 3004153240-2019-00022
• 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
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M5723INT0600220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2015
• 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: 61 YR