MAUDE Adverse Event Report: CONFORMIS, INC IDENTITY IMPRINT PS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Lot Number 972242D

Device Problem Wrong Label (4073)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2023

Event Type  malfunction  

Event Description

Identity imprint ps product contained identity imprint cr tibial tray.Ps femur and cr tibial tray implanted.

Manufacturer Narrative

A complaint was received on 21 nov 2023 (b)(4) from a conformis sales representative stating that the tibial tray implant was incorrect.The package of the imprint tray lot number 972242 should've contained a size 7 ps imprint tray implant but contained a size 7 cr tray.The error was not identified until after the cr tibial tray and ps femoral implants were both cemented in place.A soft close was done with the plan to complete the surgery the next day.The modified ps trial was left in the patient with the soft close.The second surgery was conducted on (b)(6) 2023, with a cs insert implanted.Second surgery with cs insert was successful.There are several assignable root causes for this field complaint: human error when programming the imprint tray engraving programs.Failure of following the validated and controlled qc inspection process in (b)(4).Human error when printing the interoffice label per(b)(4).System error of non-active label staying in work order in sap system.Visual inspection failures occurring in qc and in the cleanroom when inspecting and packaging this imprint cr tray with labeling of an imprint ps tray.

• Brand Name: IDENTITY IMPRINT PS
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): CONFORMIS, INC; 600 technology park drive; fourth floor; billerica MA 01821
• Manufacturer (Section G): CONFORMIS, INC; 600 research dr.; wilmington MA 01887
• Manufacturer Contact: terrance wong ; 600 technology park drive; fourth floor; billerica, MA 01821
• MDR Report Key: 18317641
• MDR Text Key: 330366875
• Report Number: 3004153240-2023-00041
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221404
• 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: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 972242D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/07/2023
• 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): Other
• Patient Age: 66 YR