MAUDE Adverse Event Report: OVERTURE ORTHOPAEDICS OVERTURETI KNEE RESURFACING SYSTEM; KNEE JOINT FEMOROTIBIAL METAL/POLYMER NON-CONSTRAINED CEMENTED PROSTHESIS

Model Number	PKG-90-OVR-300020
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for investigation.An investigation was conducted based on communication provided by the surgeon who implanted the device and performed the revision and on photographs provided by the surgeon.It is not clear from the information provided why this implant seems to have worn more than other implants of the same design.No discrepancies were noted in the manufacturing history, and no defects can be confirmed from the information provided.The root cause cannot be definitively identified.
Event or Problem Description
A bipolar overture implant was revised to a uka on (b)(6) 2026.Revision was indicated because of persistent swelling.Inspection of the well-fixed tibial component demonstrated evidence of significant polyethylene wear on the medial side.

• Brand Name: OVERTURETI KNEE RESURFACING SYSTEM
• Common Device Name: KNEE JOINT FEMOROTIBIAL METAL/POLYMER NON-CONSTRAINED CEMENTED PROSTHESIS
• Manufacturer (Section D): OVERTURE ORTHOPAEDICS; 5 peters canyon rd. suite 160; irvine CA 92606
• Manufacturer (Section G): OVERTURE ORTHOPAEDICS; 5 peters canyon rd, suite 160; irvine CA 92606
• Manufacturer Contact: jonathan nielsen ; 5 peters canyon rd, suite 160; irvine, CA 92606
• MDR Report Key: 24338139
• Report Number: 3027737826-2026-00002
• Device Sequence Number: 9799188
• Product Code: HSX
• UDI-Device Identifier: 00810129550207
• UDI-Public: (01)00810129550207(17)280831(10)LSP0027(11)230831
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K221292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 02/13/2026

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: PKG-90-OVR-300020
• Device Lot Number: LSP0027
• 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: 01/21/2026
• Initial Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown