MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON SYMMETRIC X3 PATELLA; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5550-G-360
Medical Device Problem Codes	Degraded (1153); Off-Label Use (1494)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Left medial uni to total knee revision with patella and poly wear and broken pieces.
Additional Manufacturer Narrative
This event was originally reported to stryker as an unknown device under mfr# 3005985723-2026-00030.This report is being filed to correct the change in catalog information, fda registration number and additional information.Reported event: an event regarding wear involving a triathlon patella was reported.The event was confirmed via inspection of the returned device.Method & results: -product evaluation and results: visual inspection of the returned device indicated that the patella is worn.The damage present on the anterior and posterior surfaces is consistent with delamination and material loss.The damage on the articulating surface of the patella is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient's partial uni knee was revised with patella and insert wear.The event is also considered off label as a triathlon patella was implanted with unknown mck implants.Visual inspection of the returned device indicated that the patella is worn.The damage present on the anterior and posterior surfaces is consistent with delamination and material loss.The damage on the articulating surface of the patella is consistent with burnishing, scratching, and third body indentations, which are common damage modes of uhmwpe.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: TRIATHLON SYMMETRIC X3 PATELLA
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24222437
• Report Number: 0002249697-2026-00070
• Device Sequence Number: 18287465
• Product Code: MBH
• UDI-Device Identifier: 07613327014778
• UDI-Public: 07613327014778
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2026

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: 5550-G-360
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: White