MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER

Catalog Number	5536B400
Medical Device Problem Codes	Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Insufficient Information (4580)
Date of Event	12/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The following information was provided: left knee.Patient revised due to tibia component subsiding anteriorly.Surgery sheets and x-ray attached.No other information available due to hospital policy.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
An event regarding malposition involving a triathlon baseplate was reported.The event was confirmed via clinician review - loosening and wear were also confirmed through this review.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical information by a clinical consultant indicated: "the x-rays demonstrate a left tka with significant findings including marked differential in joint space between the medial and lateral compartments with near obliteration of the medial joint space.In addition, there is evidence of tibial subsidence consistent with loss of fixation.Mechanical failure of a total knee replacement secondary to wear and loss of tibial fixation is confirmed.The implant sheet from early 2025 confirms a revision surgery was completed but no other information regarding this surgery was provided.The root cause of these mechanical failures cannot be established from the information provided." -product history review: review of the device history records could not be performed as lot details were not provided.-complaint history review:there have been no other similar events for the reported lot.Conclusions: it was reported that 'patient revised due to tibia component subsiding anteriorly.' a review of the provided medical information by a clinical consultant indicated: "the x-rays demonstrate a left tka with significant findings including marked differential in joint space between the medial and lateral compartments with near obliteration of the medial joint space.In addition, there is evidence of tibial subsidence consistent with loss of fixation.Mechanical failure of a total knee replacement secondary to wear and loss of tibial fixation is confirmed.The implant sheet from early 2025 confirms a revision surgery was completed but no other information regarding this surgery was provided.The root cause of these mechanical failures cannot be established from the information provided." no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRITANIUM BPLATE TRIATHLON S4
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24159504
• Report Number: 0002249697-2026-00051
• Device Sequence Number: 21145174
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K242831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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: 5536B400
• Device Lot Number: CTD166559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2025
• 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: 72 YR
• Patient Sex: Female