MAUDE Adverse Event Report: CONFORMIS, INC. IUNI; PARIAL KNEE REPLACEMENT SYSTEM

Model Number TPS111111102

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that replacement poly inserts have been requested for revision surgery.Reason for revision is unknown at this time.Primary surgery occurred on (b)(6) 2017.Revision surgery is planned for 10/18/2021.Review of the device history record indicates that the device was manufactured to specification.All sterilisation requirements were met.

Event Description

It was reported that replacement poly inserts have been requested for revision surgery.Reason for revision is unknown at this time.Primary surgery occurred on (b)(6)2017.Revision surgery is planned for (b)(6) 2021.

• Brand Name: IUNI
• Type of Device: PARIAL 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: kara johnson ; 600 technology park drive; billerica, MA 01821
• MDR Report Key: 12521268
• MDR Text Key: 273086620
• Report Number: 3004153240-2021-00164
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: M572TPS1111111021
• UDI-Public: M572TPS1111111021
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TPS111111102
• Device Catalogue Number: M5722INT0600210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2017
• 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: 62 YR