MAUDE Adverse Event Report: CONFORMIS CORDERA HIP SYSTEM; CORDERA HIPRX STEM

Model Number	HBS-033-0000
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Codes	Limb Fracture (4518); Periprosthetic fracture (4902)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reviewing the serial number, this was a 1 for 1 swap of hip stems for two different cases.There are no other serial numbers affected; therefore no further remedial action is warranted.After review of production records, the two devices affected went through packaging at the same time and line clearance was broken.The second swapped hip stem was dispositioned appropriately and did not leave manufacturer possession.
Event or Problem Description
The device for the case was intended to be a patient-specific size 10 cordera hiprx but it included the stem for a patient-specific size 14 cordera hiprx.The patient's femur split because it was only prepared for the size 10 and had to be cabled for completion of the procedure.This is a patient-specific case and the only impacted case was the device described in this report.No other impacted devices in the field.

• Brand Name: CORDERA HIP SYSTEM
• Common Device Name: CORDERA HIPRX STEM
• Manufacturer (Section D): CONFORMIS; 600 research drive; wilmington MA 01887
• Manufacturer (Section G): RESTOR3D, INC.; 4001 nc hwy 54; ste 3160; durham NC 27709
• Manufacturer Contact: brianna prindle ; 4001 nc hwy 54; ste 3160; durham, NC 27709
• MDR Report Key: 22467708
• Report Number: 3004173420-2025-00274
• Device Sequence Number: 4234463
• Product Code: LPH
• UDI-Device Identifier: M572HBS0330000011
• UDI-Public: M572HBS0330000011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162719
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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: HBS-033-0000
• Device Catalogue Number: HBS-033-0000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female