MAUDE Adverse Event Report: RESTOR3D, INC. CORDERA HIP SYSTEM; CORDERA ACETABULAR LINER, 36MM STANDARD

Model Number	HDL-060-C22S-000101
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reviewing both lots, this was a 1 for 1 swap of a single component of hip liners within the lot.The remainder of parts in the lots are not affected, therefore no further remedial action is required.After review of production records, the two lots affected went through cleaning at the same time prior to packaging.
Event or Problem Description
Standard acetabular liner, group c, 36mm was intended to be used but the box was mislabeled and the surgeon put in a lipped, group c, 36mm instead - hdl-060-c22l-000101.The surgeon removed the cup and opened a new liner, placing a larger cup and standard liner causing a delay in surgery.

• Brand Name: CORDERA HIP SYSTEM
• Common Device Name: CORDERA ACETABULAR LINER, 36MM STANDARD
• Manufacturer (Section D): RESTOR3D, INC.; 4001 nc hwy 54; ste 3160; durham NC 27709
• Manufacturer (Section G): RESTOR3D, INC.; 4001 nc hwy 54; ste 3160; durham NC 27709
• Manufacturer Contact: brianna prindle ; 4001 nc 54 hwy; ste 3160; durham, NC 27709 ; 7865210501
• MDR Report Key: 22385172
• Report Number: 3004153240-2025-00012
• Device Sequence Number: 15643656
• Product Code: LPH
• UDI-Device Identifier: M572HDL060C22S011
• UDI-Public: M572HDL060C22S011
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162719
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

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
• Device Model Number: HDL-060-C22S-000101
• Device Catalogue Number: HDL-060-C22S-000101
• Device Lot Number: 1842030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• 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
• Patient Age: 55 YR
• Patient Sex: Unknown