MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #3 PS ALLPOLY 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5535A311
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon ps fem component cemented; cat#5515-f-402; lot# e4a3ld.Triathlon sym patella s29x8mm; cat#5550l298; lot# ljm101.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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
The following was reported: "as noted on the 4yr visit of the follow-up questionnaire (collected over the phone), the subject answered no to her satisfaction with the results of the knee replacement.The subject commented "overall not satisfied with the results" and "reiki helps, but it isn't covered through insurance.Mobility is fine, but it just hurts." when asked about pain, the subject stated "tenderness, achiness on the left side of the knee." the subject has not had surgery on the knee since the last study visit/contact.All visits completed were conducted remotely, thus there are no radiographs to provide or physical exam notes available.".
Event or Problem Description
Update 24/june/2025 wg: as reported via per form: subject for the study completed their 5yr visit in the doctor's office on (b)(6) 2025.Per the completed follow-up questionnaire, the subject said yes to having pain in their study knee."continual stinging pain, random and not exacerbated by anything, sometimes weather changes can affect".The subject said no to not being satisfied with their knee replacement and stated "does not feel as its stable".X-rays and visit note provided.Clinical confirmed that no further information will be released by the study site.
Additional Manufacturer Narrative
Reported event: an event regarding pain involving a triathlon insert 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 remains implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a cemented right triathlon total knee arthroplasty with a polyethylene tibial component since i was able to view x-rays with the implant in place.Root cause analysis: the root cause of this event cannot be determined with certainty.Causes of a generalized assessment of "dissatisfaction" after a total knee arthroplasty are multifactorial and can be related to surgical technique in the way the implant is secured, positioned and aligned.Occult instability can also be a cause as well as other issues such as impingement or even occult infection or loosening.Patient factors including lifestyle, activity level and bmi must also be considered as well as unrealistic patient expectations.In this particular case the x-rays provided appear satisfactory and the patient's complaints are somewhat vague and non-specific.The physical examination was unremarkable.With the information provided i would not assign any causality to the implant itself." product history review: review of the device history records indicate devices were 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: the patient reported pain.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a cemented right triathlon total knee arthroplasty with a polyethylene tibial component since i was able to view x-rays with the implant in place.Root cause analysis: the root cause of this event cannot be determined with certainty.Causes of a generalized assessment of "dissatisfaction" after a total knee arthroplasty are multifactorial and can be related to surgical technique in the way the implant is secured, positioned and aligned.Occult instability can also be a cause as well as other issues such as impingement or even occult infection or loosening.Patient factors including lifestyle, activity level and bmi must also be considered as well as unrealistic patient expectations.In this particular case the x-rays provided appear satisfactory and the patient's complaints are somewhat vague and non-specific.The physical examination was unremarkable.With the information provided i would not assign any causality to the implant itself." 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 #3 PS ALLPOLY 11MM
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 21253542
• Report Number: 0002249697-2025-00126
• Device Sequence Number: 12781199
• Product Code: MBH
• UDI-Device Identifier: 07613327043532
• UDI-Public: 07613327043532
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 06/30/2024
• Device Catalogue Number: 5535A311
• Device Lot Number: 456507
• 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: 01/07/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2019
• 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; Other; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White