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

Catalog Number	HAA-050-D001
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient is experiencing a popping with their hip replacement.Review of the device history record indicates that device was manufactured to specification.
Event or Problem Description
It was reported that the patient is experiencing a popping with their hip replacement.

• 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: 8094440
• Report Number: 3004153240-2018-00266
• Device Sequence Number: 2025923
• Product Code: LPH
• UDI-Device Identifier: M572HAA050D001011
• UDI-Public: +M572HAA050D001011
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K162719
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2018

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 Expiration Date: 02/28/2019
• Device Catalogue Number: HAA-050-D001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/21/2018
• 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: 58 YR