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

Model Number	HCC032000001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the conformis cup impactor threads broke off, leaving the female threads inside the cup.The conformis 59mm cup was removed and the threads could not be removed from the cup.The cup was replaced with a 58mm signature cup.There was a light press fit achieved and two signature screws were used to secure the cup further.One cup inserter threads broke off during cup impaction and the second cup inserter appears to be cross threaded.The case was completed successfully.Review of the device history record indicates that the device was manufactured to specification.
Event or Problem Description
It was reported that the conformis cup impactor threads broke off, leaving the female threads inside the cup.The conformis 59mm cup was removed and the threads could not be removed from the cup.The cup was replaced with a 58mm signature cup.There was a light press fit achieved and two signature screws were used to secure the cup further.One cup inserter threads broke off during cup impaction and the second cup inserter appears to be cross threaded.The case was completed successfully.

• 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: 8596519
• Report Number: 3004153240-2019-00111
• Device Sequence Number: 11307742
• Product Code: LPH
• UDI-Device Identifier: M572HCC0320000011
• UDI-Public: +M572HCC0320000011
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 05/09/2019

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: 04/16/2019
• Initial Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR