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 Codes	Malposition of Device (2616); Osseointegration Problem (3003); Unintended Movement (3026)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Insufficient Information (4580)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "original surgery approximately 1 year ago.Revised for tibial subsidence." rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event an event regarding malposition and loosening involving a triathlon baseplate was reported.The event was confirmed via clinician review.Method & results -product evaluation and results: visual: photos were provided for review, a review of provided photos indicate recently explanted devices covered in blood and tissue.Nothing remarkable observed.-clinician review: a review of the provided medical information by a clinical consultant indicated: "the x-ray provided shows a press fit tka.The tibial component shows latencies about the keel and has subsided consistent with loss of fixation.The implant sheet documents revision of the tibial component to a universal baseplate and cemented stem.Loss of fixation of a press fit tibial component requiring revision tka surgery is confirmed.The cause of this biologic/mechanical failure cannot be determined from the limited documentation provided." -product history review: review of the device history records could not be performed as lot details were not provided.-complaint history review: a complaint history review could not be performed as lot code information was unknown.Conclusions: a review of the provided medical information by a clinical consultant indicated: "the x-ray provided shows a press fit tka.The tibial component shows latencies about the keel and has subsided consistent with loss of fixation.The implant sheet documents revision of the tibial component to a universal baseplate and cemented stem.Loss of fixation of a press fit tibial component requiring revision tka surgery is confirmed.The cause of this biologic/mechanical failure cannot be determined from the limited documentation 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.
Event or Problem Description
No new information.

• 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 NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22580629
• Report Number: 0002249697-2025-00709
• Device Sequence Number: 7082498
• Product Code: MBH
• UDI-Device Identifier: 07613327041514
• UDI-Public: 07613327041514
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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 Catalogue Number: 5536B600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 11/19/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 154 KG