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

Model Number	HBS033000001
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient will undergo a tha revision.The reason for the revision is due to dislocation.The patient has dislocated and unknown if any trauma or incident led to this.The cause of dislocation is unknown.The patient was revised with a +8/xl and a lipped liner for extended leg length and offset from original procedure.Primary surgery occurred on (b)(6) 2020.Revision surgery is planned for (b)(6) 2021.Review of the device history record indicates that the device was manufactured to specification.All sterilisation requirements were met.
Event or Problem Description
It was reported that the patient will undergo a tha revision.The reason for the revision is due to dislocation.Primary surgery occurred on (b)(6) 2020.Revision surgery is planned for (b)(6) 2021.

• Brand Name: ITOTAL HIP G2
• Common Device Name: TOTAL HIP REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• MDR Report Key: 12214978
• Report Number: 3004153240-2021-00110
• Device Sequence Number: 4002509
• Product Code: LPH
• UDI-Device Identifier: M572HBS0330000011
• UDI-Public: M572HBS0330000011
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K192198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 07/22/2021

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: HBS033000001
• Device Catalogue Number: HBS-033-0012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/22/2021
• 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: 77 YR