MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S6; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5536B600
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right knee was revised due to the posterior medial third of the baseplate and the insert breaking off.
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a triathlon baseplate was reported.The event was confirmed via inspection of the returned devices.Method & results: -device evaluation and results: visual inspection & material analysis: review of the tritanium tibial baseplate, catalogue # 5536-b-600, lot code ctd51601 and tibial insert, catalogue # 5531-g-012-e, lot code t93152 confirmed fracture of the device.Characterisation using stereo microscopy confirmed the presence of embedded debris on both the articulating and distal surfaces of the insert.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture through the baseplate in fatigue.Characterisation using stereo microscopy confirmed the fracture of the insert and evidence of embedded debris on both the articulating and distal surfaces of the insert.No manufacturing or material related defects were observed on the examined areas of the components.-clinician review: no medical records were received for review with a clinical consultant.-device history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to fractured devices.Visual inspection & material analysis: review of the tritanium tibial baseplate, catalogue # 5536-b-600, lot code ctd51601 and tibial insert, catalogue # 5531-g-012-e, lot code t93152 confirmed fracture of the device.Characterisation using stereo microscopy confirmed the presence of embedded debris on both the articulating and distal surfaces of the insert.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture through the baseplate in fatigue.Characterisation using stereo microscopy confirmed the fracture of the insert and evidence of embedded debris on both the articulating and distal surfaces of the insert.No manufacturing or material related defects were observed on the examined areas of the components.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 S6
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21940909
• Report Number: 0002249697-2025-00456
• Device Sequence Number: 9055880
• Product Code: MBH
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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 Expiration Date: 10/03/2025
• Device Catalogue Number: 5536B600
• Device Lot Number: CTD51601
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2020
• 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 Sex: Male