MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah SCORPIO NRG X3 PS TIBIAL INS NO 5 10MM; prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal

Catalog Number	82-7-0510
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had an index left tka on (b)(6) 2013.The patient developed instability and hyperextension, and was revised on (b)(6) 2025.All components exchanged, except the patella.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.The following devices were also listed in this report: scorpio nrg ps fem no 6 left; cat#: 81-4406l; lot#: mmjx6e; series 7000 standard tibia; cat#: 7115-0005; lot#: mmd1jk.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: SCORPIO NRG X3 PS TIBIAL INS NO 5 10MM
• Common Device Name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal
• Manufacturer (Section D): Stryker Orthopaedics-Mahwah; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): Stryker Orthopaedics-Mahwah; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50418425
• Report Number: 0002249697-2026-00743
• Device Sequence Number: 18789711
• Product Code: JWH
• UDI-Device Identifier: 07613327030938
• UDI-Public: 07613327030938
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K071991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Study
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 82-7-0510
• Device Lot Number: MMK2M8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2013
• 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: Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 131 LB