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

Model Number HCC032000001

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the threaded tip of the inserter broke inside the cup and was not noticed until the cup was fully seated.The surgeon elected to leave the broken portion of the inserter inside in the cup as it was not able to be removed and was not impinging the liner or any other components.The rest of the case was completed without issue.Review of the device history record indicates that the device was manufactured to specification.

Event Description

It was reported that the threaded tip of the inserter broke inside the cup and was not noticed until the cup was fully seated.The surgeon elected to leave the broken portion of the inserter inside in the cup as it was not able to be removed and was not impinging the liner or any other components.The rest of the case was completed without issue.

• 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 ; 7813459093
• MDR Report Key: 9329164
• MDR Text Key: 174179726
• Report Number: 3004153240-2019-00248
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: M572HCC0320000011
• UDI-Public: +M572HCC0320000011
• 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: 10/18/2019

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: HCC032000001
• Device Catalogue Number: HCC-032-0000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2019
• 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: 64 YR