MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL IDENTITY CR; TOTAL KNEE REPAIR SYSTEM

Model Number	TCR-101-1112
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's husband called in stated the patient has had two conformis knee implants, it's been three years since the first knee implant with no issues.This second knee has now become infected.He stated the hospital has talked about cleaning it out.Dr.Silver is in the caribbean and he cannot contact him.He stated the knee infection has went to his wife's back and she is going to have to have surgery on it and they keep getting conflicting information.No further information was received from the patient or surgeon.The device manufacturing records were reviewed, and the device was manufactured per the specifications.All sterilisation requirements were met.
Event or Problem Description
Patient's husband called in stated the patient has had two conformis knee implants, it's been three years since the first knee implant with no issues.This second knee has now become infected.He stated the hospital has talked about cleaning it out.Dr.Silver is in the caribbean and he cannot contact him.He stated the knee infection has went to his wife's back and she is going to have to have surgery on it and they keep getting conflicting information.

• Brand Name: ITOTAL IDENTITY CR
• Common Device Name: TOTAL KNEE REPAIR 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: 15341247
• Report Number: 3004153240-2022-00134
• Device Sequence Number: 14760280
• Product Code: JWH
• UDI-Device Identifier: M572TCR1011112111
• UDI-Public: M572TCR1011112111
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K210809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TCR-101-1112
• Device Catalogue Number: TCR-101-1112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Unknown