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

Model Number HAA050D00101

Device Problems Difficult to Remove (1528); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the surgeon had difficulty removing the trial liner after implanting the final stem.The surgeon was unable to place the planned liner with the stem in place.The surgeon had to remove the stem twice to place the planned liner.The surgeon scuffed the neck of the stem while removing it due to the lack of a stem removal tool.The case was completed successfully.Review of the device history record indicates that the device was manufactured to specification.

Event Description

It was reported that the surgeon had difficulty removing the trial liner after implanting the final stem.The surgeon was unable to place the planned liner with the stem in place.The surgeon had to remove the stem twice to place the planned liner.The surgeon scuffed the neck of the stem while removing it due to the lack of a stem removal tool.The case was completed successfully.

• Brand Name: CONFORMIS HIP SYSTEM
• Type of Device: HIP REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• Manufacturer (Section G): CONFORMIS, INC.; 600 research drive; wilmington MA 01887
• Manufacturer Contact: paul smolenski ; 600 technology park drive; billerica, MA 01821 ; 7813459161
• MDR Report Key: 8566402
• MDR Text Key: 143679356
• Report Number: 3004153240-2019-00106
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: M572HAA050D001011
• UDI-Public: +M572HAA050D001011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162719
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2019

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
• Device Operator: Health Professional
• Device Model Number: HAA050D00101
• Device Catalogue Number: HAA-050-D020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 04/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR