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

Catalog Number	PKG-90-OVR-300022
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 06/23/2025 overture was notified by a sales representative, that a patient required revision due to tibial implant loosening.On (b)(6) 2025 the overture implant was removed and replaced with a unicompartmental knee arthroplasty device.The overture implant was implanted on (b)(6) 2025.

• 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: kira quintana ; 5 peters canyon road, suite 160; irvine, CA 92606 ; 9495569695
• MDR Report Key: 22523541
• Report Number: 3027737826-2025-00001
• Device Sequence Number: 12782178
• Product Code: HSX
• UDI-Device Identifier: 00810129550214
• UDI-Public: (01)00810129550214(17)280831(10)LSP0028(11)230831
• Combination Product (Y/N): N
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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 Catalogue Number: PKG-90-OVR-300022
• Device Lot Number: LSP0028
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/16/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown