MAUDE Adverse Event Report: CONFORMIS, INC. IUNI G2; UNICONDYLAR KNEE REPLACEMENT SYSTEM

Catalog Number M5722INT0600220

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Hemorrhage/Bleeding (1888); Discomfort (2330)

Event Date 05/18/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient suffered discomfort and bleeding into the joint for months post-surgery.During the revision on (b)(6) 2021 it was determined that there was premature loosening of the prosthesis.There were also signs of wear on the poly insert and plastic discoloration.Review of the device history record indicates that the device was manufactured to specification.

Event Description

It was reported that the patient suffered discomfort and bleeding into the joint for months post-surgery.During the revision on (b)(6) 2021 it was determined that there was premature loosening of the prosthesis.There were also signs of wear on the poly insert and plastic discoloration.

• Brand Name: IUNI G2
• Type of Device: UNICONDYLAR 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: 12021342
• MDR Text Key: 257133575
• Report Number: 3004153240-2021-00091
• Device Sequence Number: 1
• Product Code: HSX
• 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: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M5722INT0600220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2020
• 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: 79 YR