MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah TRI TS FEMUR SZ6 LEFT; prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal

Catalog Number	5512-F-601
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left knee was revised due to the following: loosening of the femoral stem and breakage of the femoral stem where it threads into the femoral component, loosening of the tibial stem which was also broken.The ts knee was removed and another ts knee implanted with a revision baseplate, stems and cones.Rep can provide images, otherwise confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRI TS FEMUR SZ6 LEFT
• 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 ; +1(201)831-5000
• MDR Report Key: 50303259
• Report Number: 0002249697-2026-00716
• Device Sequence Number: 10701475
• Product Code: JWH
• UDI-Device Identifier: 07613327026597
• UDI-Public: 07613327026597
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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 Catalogue Number: 5512-F-601
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 176 LB