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

Model Number	HDL-060-C22S-000101
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a hip replacement procedure, the rep opened two boxes labeled and standard cordera hip liners to discover that both boxes contained hooded liners.The surgeon had to use a hooded liner to complete the operation instead of the planned standard liner.
Additional Manufacturer Narrative
The cordera hip replacement system liners provided for this case were labeled as standard-style liners.When the boxes were opened in the operating room, it was discovered that they contained hooded-style liners instead of the standard liners as labeled.The two boxes labeled as standard shared identical lot numbers; the two provided boxes labeled as hooded liners were opened to confirm that these were packaged and labled as intended.The boxes labeled as hooded liners did contain the correct item.As a result, the surgeon had no option other than to complete the operation using a hooded liner, and completed the remainder of the operation as planned.

• Brand Name: CORDERA HIP SYSTEM
• Common Device Name: CORDERA HIP SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 research dr.; wilmington MA 01887
• Manufacturer (Section G): CONFORMIS, INC.; 600 research dr.; wilmington MA 01887
• Manufacturer Contact: brianna prindle ; 60 research dr.; wilmington, MA 01887
• MDR Report Key: 21699698
• Report Number: 3004153240-2025-00010
• Device Sequence Number: 8592844
• Product Code: LPH
• UDI-Device Identifier: M572HDL060C22S011
• UDI-Public: M572HDL060C22S011
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K202484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace,Recall
• Type of Report: Initial
• Report Date (Section B): 03/25/2025

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 Model Number: HDL-060-C22S-000101
• Device Lot Number: 1788258
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown