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

Model Number	HAA050D00N01
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the trial head had stuck on the implant during surgery.The surgeon utilised a bone screw to remove the trial head.The surgeon had to utilise force with a bone tamp and mallet to release the trial head.There was a major delay of 20 minutes during the operation.Review of the device history record indicates that the device was manufactured to specification.All sterilisation requirements were met.
Event or Problem Description
It was reported that the trial head had stuck on the implant during surgery.The surgeon utilised a bone screw to remove the trial head.The surgeon had to utilise force with a bone tamp and mallet to release the trial head.There was a major delay of 20 minutes during the operation.

• Brand Name: CORDERA HIP SYSTEM
• Common Device Name: TOTAL HIP REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• MDR Report Key: 12221227
• Report Number: 3004153240-2021-00113
• Device Sequence Number: 4440621
• 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
• Device Implanted Year: 2021
• 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): 07/23/2021

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
• Operator of Device: Health Professional
• Device Model Number: HAA050D00N01
• Device Catalogue Number: HAA-050-D00N
• Device Lot Number: 757011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 07/23/2021
• 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: 54 YR