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

Model Number	HDL060E34S01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the plus 4 cup liner would not lock in or seat inside the cup after five different attempts.The case was completed successfully with the standard plus 2 liner.Review of the device history record indicates that the device was manufactured to specification.
Event or Problem Description
It was reported that the plus 4 cup liner would not lock in or seat inside the cup after five different attempts.The case was completed successfully with the standard plus 2 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: 8865133
• Report Number: 3004153240-2019-00180
• Device Sequence Number: 2196425
• Product Code: LPH
• UDI-Device Identifier: M572HDL060E34S011
• UDI-Public: +M572HDL060E34S011
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K162719
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HDL060E34S01
• Device Catalogue Number: HDL-060-E34S
• Device Lot Number: 617055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR