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

Model Number	HBS033000001
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the stem hung up about 4 mm proud and the surgeon needed an extraction instrument to get the implant out.The surgeon trailed with shorter heads, but ultimately stayed with the planned length due to offset consequences.The patient leg length was left longer than the plan as a result.Review of the device history record indicates that the device was manufactured to specification.
Event or Problem Description
It was reported that the stem hung up about 4 mm proud and the surgeon needed an extraction instrument to get the implant out.The surgeon trailed with shorter heads, but ultimately stayed with the planned length due to offset consequences.The patient leg length was left longer than the plan as a result.

• 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: 11668014
• Report Number: 3004153240-2021-00056
• Device Sequence Number: 3029213
• Product Code: LPH
• UDI-Device Identifier: M572HBS0330000011
• UDI-Public: +M572HBS0330000011
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K192198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 04/13/2021

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: 03/25/2021
• Initial Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR