MAUDE Adverse Event Report: CONFORMIS, INC. CONFORMIS ITOTAL CR TOTAL KNEE REPLACEMENT; TOTAL KNEE ARTHROPLASTY

Model Number	TCR-111-1111-020102
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Limb Pain (4836)
Date of Event	04/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient experienced pain following total knee arthroplasty.Approximately 42 months following the initial surgery, the patient underwent revision surgery.The device was not returned to the manufacturer for evaluation, and determination of potential defect is pending review of production records.
Event or Problem Description
It was reported that the patient experienced pain in the affected knee following total knee replacement surgery.Approximately 42 months following initial surgery, the patient underwent revision surgery on the same knee.
Event or Problem Description
It was reported that the patient experienced pain in the affected knee following total knee replacement surgery.Approximately 42 months following initial surgery, the patient underwent revision surgery on the same knee.
Additional Manufacturer Narrative
It was reported that the patient experienced pain following total knee arthroplasty.Approximately 42 months following the initial surgery, the patient underwent revision surgery.The device was not returned to the manufacturer for evaluation, and determination of potential defect is pending review of production records.

• Brand Name: CONFORMIS ITOTAL CR TOTAL KNEE REPLACEMENT
• Common Device Name: TOTAL KNEE ARTHROPLASTY
• Manufacturer (Section D): CONFORMIS, INC.; 600 research dr.; wilmington MA 01887
• Manufacturer (Section G): CONFORMIS, INC.; 600 research drive; wilmington MA 01887
• Manufacturer Contact: brianna prindle ; 600 research drive; wilmington, MA 01887
• MDR Report Key: 21938299
• Report Number: 3004153240-2025-00011
• Device Sequence Number: 14791214
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K180906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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-111-1111-020102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Unknown