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

Model Number	HBS033000001
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient was revised to a depuy corail stem.The patient-specific stem was not able to get fully seated and sat about 6-7mm proud while also adding additional leg length.The main factor for the revision was significant scoliosis and pelvic obliquity in the patient which wasn't fully appreciated by the office x-rays, i-view, or the surgeon preoperatively.Review of the device history record indicates that the device was manufactured to specification.
Event or Problem Description
It was reported that the patient was revised to a depuy corail stem.The patient-specific stem was not able to get fully seated and sat about 6-7mm proud while also adding additional leg length.The main factor for the revision was significant scoliosis and pelvic obliquity in the patient which wasn't fully appreciated by the office x-rays, i-view, or the surgeon preoperatively.

• 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: 12110222
• Report Number: 3004153240-2021-00100
• Device Sequence Number: 3490400
• Product Code: LPH
• UDI-Device Identifier: M572HBS0330000011
• UDI-Public: +M572HBS0330000011
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K192198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted 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): 07/02/2021

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-033-0000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 07/02/2021
• 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: 62 YR