MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON ASYM PATELLA A35X10; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5551L350
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Insufficient Information (4580)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Patient report: "i am contacting you in regard to patella implant that appears to have a fracture.This was implanted at the end of (b)(6) 2025 - there has been no trauma.".
Additional Manufacturer Narrative
Corrected data: manufacturing site for devices.An event regarding crack/fracture involving a triathlon patella 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 remained implanted.Clinician review: a review of medical records with a clinical consultant indicated "confirmation of event: i can confirm that the patient had a total knee arthroplasty with a cemented patella component since i was able to review an x-ray with the implant in place.I cannot confirm the exact date.I cannot confirm a fracture of the patella component nor anything that would lead me to believe there was surgeon error.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of para patella pain with instability, crepitus and functional limitations are multi factorial including scar buildup, impingement, maltracking, and less likely loosening or mechanical failure (which i doubt).A bone scan might be of value to see if there is increased activity about the interior aspect of the patella, although as i said, i doubt fracture of the patella bone itself, and i don¿t see any fracture of the implant itself.Product history review: review of the device history records indicate the device was 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: it was reported that the patient was revised due to fracture of the patellar component.A review of medical records with a clinical consultant indicated "confirmation of event: i can confirm that the patient had a total knee arthroplasty with a cemented patella component since i was able to review an x-ray with the implant in place.I cannot confirm the exact date.I cannot confirm a fracture of the patella component nor anything that would lead me to believe there was surgeon error.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of para patella pain with instability, crepitus and functional limitations are multi factorial including scar buildup, impingement, maltracking, and less likely loosening or mechanical failure (which i doubt).A bone scan might be of value to see if there is increased activity about the interior aspect of the patella, although as i said, i doubt fracture of the patella bone itself, and i don¿t see any fracture of the implant itself.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
No new information.

• Brand Name: TRIATHLON ASYM PATELLA A35X10
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22355948
• Report Number: 0002249697-2025-00644
• Device Sequence Number: 8759409
• Product Code: MBH
• UDI-Device Identifier: 07613327049862
• UDI-Public: 07613327049862
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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: 5551L350
• Device Lot Number: LNN973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2025
• 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: Other
• Patient Sex: Unknown