MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL IDENTITY PS; BICOMPARTMENTAL KNEE REPAIR SYSTEM

Model Number	TPS-101-1112
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the ps femoral implant packaging had a hole through both layers of packaging, breaching the sterile barrier.This was discovered during surgery; the surgeon chose to re-sterilize the implant.This re-sterilization process takes around 1-2 hours and needed to be completed while the patient was under anesthesia.This was a major delay to the surgery.The device history record was reviewed, and the implant was designed and manufactured per the specifications.All sterilisation requirements were met.
Event or Problem Description
It was reported that the ps femoral implant packaging had a hole through both layers of packaging, breaching the sterile barrier.This was discovered during surgery; the surgeon chose to re-sterilize the implant.This re-sterilization process takes around 1-2 hours and needed to be completed while the patient was under anesthesia.This was a major delay to the surgery.

• Brand Name: ITOTAL IDENTITY PS
• Common Device Name: BICOMPARTMENTAL 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: elizabeth haines ; 600 technology park drive; billerica, MA 01821
• MDR Report Key: 15829374
• Report Number: 3004153240-2022-00174
• Device Sequence Number: 17641874
• Product Code: JWH
• UDI-Device Identifier: M572TPS1011112111
• UDI-Public: M572TPS1011112111
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K210252
• 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): 11/18/2022

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: TPS-101-1112
• Device Catalogue Number: TPS-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: 10/20/2022
• Initial Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2022
• 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: 83 YR
• Patient Sex: Unknown