MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL HIP G2; HIP REPLACEMENT SYSTEM

Model Number	HBS033000001
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the surgeon had troubles with the fit and positioning of the patient-specific stem.The surgeon was unable to fully seat the size 13 stem which sat 10 mm proud.He completed the surgery with a smaller stem from another vendor while still utilizing the conformis cup, liner, and head.Review of the device history record indicates that the device was manufactured to specification.The surgeon for case did not utilize the patient-specific f2 jig provided with the implant system.Failure to utilize the f2 jig can lead to improper broach positioning which will cause the stem to sit proud.
Event or Problem Description
It was reported that the surgeon had troubles with the fit and positioning of the patient-specific stem.The surgeon was unable to fully seat the size 13 stem which sat 10 mm proud.He completed the surgery with a smaller stem from another vendor while still utilizing the conformis cup, liner, and head.

• Brand Name: ITOTAL HIP G2
• Common Device Name: HIP REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• MDR Report Key: 11802851
• Report Number: 3004153240-2021-00069
• Device Sequence Number: 16418753
• Product Code: LPH
• UDI-Device Identifier: M572HBS0330000011
• UDI-Public: +M572HBS0330000011
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K192198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/10/2021

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
• Operator of Device: Health Professional
• Device Model Number: HBS033000001
• Device Catalogue Number: HBS-033-0000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR