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

Catalog Number	5551-G-350-E
Medical Device Problem Codes	Fracture (1260); Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
Revised patella implant due to implant loosening and implant fracture whilst in situ.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a triathlon patella was reported.The event of crack/fracture was confirmed via review of the provided photographs.The event for loosening was not confirmed.Method & results: -product evaluation and results: the device was not returned for inspection; however, photographs were provided for review.The photographs show a recently explanted patella implant with biological on it.The device is cracked down the center and appears to be significantly worn.-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.Conclusion: it was reported that 'revised patella implant due to implant loosening and implant fracture whilst in situ.' the device was not returned for inspection; however, photographs were provided for review.The photographs show a recently explanted patella implant with biological on it.The device is cracked down the center and appears to be significantly worn.No further investigation is possible at this tome.If device/ additional information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
No new information.

• Brand Name: TRIATHLON ASYMMETRIC 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23733470
• Report Number: 0002249697-2025-01418
• Device Sequence Number: 15890456
• Product Code: MBH
• UDI-Device Identifier: 07613327314793
• UDI-Public: 07613327314793
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172634
• 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): 04/09/2026

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 Catalogue Number: 5551-G-350-E
• Device Lot Number: 2065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2022
• 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