MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah TRITANIUM BPLATE TRIATHLON S2; Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, co

Catalog Number	5536B200
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Inadequate Osseointegration (2646)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
This pi is for the 2025 right knee revision.It was reported via phone; i had a total knee replacement on (b)(6) 2023 on my right knee.The knee felt hot, pain and i was unable to bend it hardly any movement in it.My dr.Examined me in (b)(6) and stated it was loose.I had a revision in (b)(6) 2023 however the issue persisted.In (b)(6) i had another surgery to clean the knee.The issue still persisted.Then in (b)(6) 2025 a different dr.Performed a bone scan and found that the knee was still loose.Another revision was performed all the stryker implants were explanted and replaced with competitor implants.Patient also reported that they had a left partial knee replacement on (b)(6) 2022 with stryker implants.They are experiencing clicking, pain and looseness.Revision due to loose total knee.Revised to competitor devices.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.

• Brand Name: TRITANIUM BPLATE TRIATHLON S2
• Common Device Name: Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, co
• Manufacturer (Section D): Stryker Orthopaedics-Mahwah; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): Stryker Orthopaedics-Limerick; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50159828
• Report Number: 0002249697-2026-00674
• Device Sequence Number: 9261263
• Product Code: MBH
• UDI-Device Identifier: 07613327041590
• UDI-Public: 07613327041590
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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: 5536B200
• Device Lot Number: CTD93891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2002
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 183 LB