MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO TS FEM W/LFIT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	76-4109R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: this pi is for the 2025 revision.As per pss implant request case (b)(4): failed right knee total knee with broken components; morbid obesity with bmi greater than 44.This patient has a # 9 scorpio ts femoral component with a 23x80 stem extender.There is a fracture of the implant at the stem femoral junction.The patient has a #13 scorpio tibial tray with 10mm augments medial and lateral and a 16x80 stem extender.Also implanted in tibia is a 59mm trabecular metal cone (zimmer).Currently a size 11 8mm scorpio ps tibial bearing is implanted.Needed for this next revision is an insert (ps or ts) to mate with a triathlon ts femoral component.The surgeon need to leave the current tibial construct implanted.Patient has had several knee revisions.2005 both components revised, 2006 tibial insert revised, 2014 the tibial tray and insert revised.

• Brand Name: SCORPIO TS FEM W/LFIT
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23346346
• Report Number: 0002249697-2025-01146
• Device Sequence Number: 9544843
• Product Code: JWH
• UDI-Device Identifier: 07613327029208
• UDI-Public: 07613327029208
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K994128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

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 Expiration Date: 06/30/2010
• Device Catalogue Number: 76-4109R
• Device Lot Number: K05H1437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2005
• 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: 74 YR
• Patient Sex: Male