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 Codes	Material Fragmentation (1261); Naturally Worn (2988)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On october 14, 2025, overture was notified of a revision surgery involving the removal of tibial 20mm and femoral oblong 22.5x40mm implants, initially implanted on (b)(6) 2024.The revision was performed to convert the overture system to a total knee replacement after the patient reported knee pain.The surgeon stated that the implants were well fixed, but there were poly fragments in the knee.The tibial polyethylene articulation surface was worn and pitted.The femoral component appeared unremarkable.

• 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 road suite 160; irvine 92606
• Manufacturer Contact: kira quintana ; 5 peters canyon road, suite 160; irvine, CA 92606 ; 9495569695
• MDR Report Key: 23555600
• Report Number: 3027737826-2025-00003
• Device Sequence Number: 21244146
• 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: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K221292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/12/2025

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: PKG-90-OVR-300020
• Device Lot Number: LSP0027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 11/14/2025
• 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