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

Model Number	HAA050D00N01
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the cordera plastic trial neck broke while the surgeon tried to dislocate the hip.There were no delays in surgery nor were there any delays in the procedure.Review of the device history record indicates that the device was manufactured to specification.
Event or Problem Description
It was reported that the cordera plastic trial neck broke while the surgeon tried to dislocate the hip.There were no delays in surgery nor were there any delays in the procedure.

• Brand Name: CORDERA HIP
• Common Device Name: HIP REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• MDR Report Key: 11566246
• Report Number: 3004153240-2021-00030
• Device Sequence Number: 4206438
• Product Code: LPH
• UDI-Device Identifier: M572HAA050D00N011
• UDI-Public: +M572HAA050D00N011
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K202484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2021

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: HAA050D00N01
• Device Catalogue Number: HAA-050-D00N
• Device Lot Number: 757016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR