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

Model Number	HCC032000001
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient's posterior column of the acetabulum was likely fractured during surgery causing shifting of the cup.A revision surgery is planned to replace the cup and liner.Review of the device history record indicates that the device was manufactured to specification.
Event or Problem Description
It was reported that the patient's posterior column of the acetabulum was likely fractured during surgery causing shifting of the cup.A revision surgery is planned to replace the cup and liner.

• Brand Name: CONFORMIS HIP SYSTEM
• Common Device Name: HIP REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• MDR Report Key: 8668526
• Report Number: 3004153240-2019-00137
• Device Sequence Number: 19397391
• Product Code: LPH
• UDI-Device Identifier: M572HCC0320000011
• UDI-Public: +M572HCC0320000011
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K162719
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2019

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: HCC032000001
• Device Catalogue Number: HCC-032-0000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 06/04/2019
• 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: 63 YR