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

Model Number HBS033000001

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 12/23/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that the planned stem size for the patient was too large to accommodate the femoral canal.The surgeon made a conversion to an off-the-shelf hip replacement and completed the surgery successfully.Review of the device history record indicates that the device was manufactured to specification.

Event Description

It was reported that the planned stem size for the patient was too large to accommodate the femoral canal.The surgeon made a conversion to an off-the-shelf hip replacement and completed the surgery 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: emmanuel nyakako ; 600 technology park drive; billerica, MA 01821 ; 7813459164
• MDR Report Key: 9565682
• MDR Text Key: 174270522
• Report Number: 3004153240-2020-00013
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: M572HBS0330000011
• UDI-Public: +M572HBS0330000011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192198
• 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: 01/08/2020

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
• Device Operator: Health Professional
• Device Model Number: HBS033000001
• Device Catalogue Number: HBS-033-0000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 77 YR