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

Model Number	HCC032B05601
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the surgeon noticed that the cup had shifted right before closing up the patient.It was noted that the surgeon doesn't use screws for most cases.The surgeon had to remove the liner from the cup and reposition it using screws to successfully complete the surgery, but the issue resulted in a 45 minute delay in the procedure.Review of the device history record indicates that the device was manufactured to specification.
Event or Problem Description
It was reported that the surgeon noticed that the cup had shifted right before closing up the patient.It was noted that the surgeon doesn't use screws for most cases.The surgeon had to remove the liner from the cup and reposition it using screws to successfully complete the surgery, but the issue resulted in a 45 minute delay in the procedure.

• Brand Name: ITOTAL HIP G2
• Common Device Name: HIP REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica, ma
• MDR Report Key: 10393037
• Report Number: 3004153240-2020-00141
• Device Sequence Number: 1984948
• Product Code: LPH
• UDI-Device Identifier: M572HCC032B056011
• UDI-Public: +M572HCC032B056011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2020

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: HCC032B05601
• Device Catalogue Number: HCC-032-B056
• Device Lot Number: 727127
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/11/2020
• 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: 34 YR