MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S4; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5536B400
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Revision scheduled for a uncemented triathlon knee.
Additional Manufacturer Narrative
An event regarding size/fit issue involving a triathlon baseplate was reported.The event was not confirmed.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: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Revision scheduled for a uncemented triathlon knee.Update: the participant had continuing complaints of pain.It seems that there was an overhanging of the tibial plateau, which was possibly due to a too large size tibial plateau.Since smaller surgeries do not seem to help to resolve the complaints, it was decided to do a full revision to downsize the size of the components.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding size/fit issue involving a triathlon baseplate was reported.The event was not confirmed.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: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or 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, 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 NJ NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19747011
• Report Number: 0002249697-2024-00994
• Device Sequence Number: 9015593
• Product Code: MBH
• UDI-Device Identifier: 07613327041491
• UDI-Public: 07613327041491
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K123486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2025

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: 04/30/2026
• Device Catalogue Number: 5536B400
• Device Lot Number: CTD58977
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 09/27/2024; 09/04/2025
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 10/21/2024; 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2021
• 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 Sex: Unknown