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

Model Number	HCC032000001
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/23/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: HIP REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• MDR Report Key: 9329164
• Report Number: 3004153240-2019-00248
• Device Sequence Number: 3042803
• Product Code: LPH
• UDI-Device Identifier: M572HCC0320000011
• UDI-Public: +M572HCC0320000011
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K162719
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: HCC032000001
• Device Catalogue Number: HCC-032-0000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 11/15/2019
• 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: 64 YR