MAUDE Adverse Event Report: CONFORMIS INC. ITOTAL IDENTITY PS KNEE REPLACEMENT SYSTEM; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED

Model Number TPS101111201

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 01/17/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient developed an infection after the primary surgery which was done (b)(6).There have been no other reports of procedural or post-operative complications for this patient.The ncmr records for this patient were reviewed.Tq-22-0031 was noted but was cleared prior to surgery being performed.No design related ncmrs noted.The device was manufactured and processed through lts-v done on 02/07/2022.All cycles were completed without issues.Review indicates that the device was designed and manufactured to specification.All sterilization requirements were met.Infection is a known complication of joint replacement surgery.Cause of infection cannot be conclusively determined with available information.

Event Description

The surgeon has ordered the following replacement parts for intended revision surgery.Itotal identity ps tibial insert 10mm right.Itotal identity ps tibial insert,, 6mm, right.Itotal identity ps tibial insert, 8mm, right.Original surgery date: (b)(6) 2022.New surgery date: (b)(6) 2023.

• Brand Name: ITOTAL IDENTITY PS KNEE REPLACEMENT SYSTEM
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED
• Manufacturer (Section D): CONFORMIS INC.; 600 technology park drive; fourth floor; billerica 01821
• Manufacturer (Section G): CONFORMIS INC; 600 research bvld; wilmington MA 01887
• Manufacturer Contact: elizabeth haines ; 600 technology park drive; billerica, MA 01821
• MDR Report Key: 16273374
• MDR Text Key: 308492273
• Report Number: 3004153240-2023-00004
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: M572TPS1011112011
• UDI-Public: M572TPS1011112011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203447
• 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: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TPS101111201
• Device Catalogue Number: TPS-101-1112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 68 YR