MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 4 TRIATH TS PLUS TIB INS X3 POLY 19MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-419-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject came into the office for their 1-yr postop visit for the 76 triathlon cone augments outcomes study on (b)(6) 2023.Subject states excessive knee pain at the time of the visit.Per clinic note, implant appears in overall good alignment and position, no signs of loosening and no signs of osteolysis no other bony or osseous abnormality.Patient is having knee pain with active extension of knee due to the fact that the patella is thinned out from the debridement we had to do to clean out the infection that was in the knee.Discussed with patient trying a nerve ablation to treat the knee pain and will try to get this done through pain management physician.Subject has not returned for the 2-yr postop visit.Dr.Confirmed uncertain relationship of device for ae.
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.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.
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: 'confirmation of event: i can confirm that the patient underwent removal of the implant with insertion of an antibiotic impregnated spacer, as well as a revision total knee arthroplasty with reinsertion of an implant since i was able to review the operation reports for both of these procedures as well as the x-rays.I have no specific information about his primary procedure which was said to be in 2015.I can also confirm that the patient complained of excessive pain in the knee at the 2 year visit since i was able to review the office notes.Root cause analysis: the root cause of these events cannot be determined with certainty.The causes of infection three to four months after index total knee arthroplasty are multifactorial.Most likely cause of infection at three or four months is that the wound was seeded from a remote cause or some concomitant infection.Patient host factors also contribute including the patient's general medical condition, the state of his immune system and his bmi.It is also possible that the wound was contaminated at the original surgery or that there may have been wound healing issues and drainage which we don't know about.The causes of recurrent infection following two-stage revision and reimplantation are also multifactorial with the same possible contributors.The root cause of the patient¿s excessive pain complaint cannot determined with certainty.However it is not uncommon for patient¿s who under revision for infection with removal of the patella implant with thinning of the patella to experience pain and crepitation.In this case it is likely that the pain is from the residual condition of the patella.I would not assign any causality to the implants themselves.' - device history review: all 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 reported lot.Conclusions: a review of the provided medical records by a clinical consultant indicated: 'the root cause of the patient¿s excessive pain complaint cannot determined with certainty.However it is not uncommon for patient¿s who under revision for infection with removal of the patella implant with thinning of the patella to experience pain and crepitation.In this case it is likely that the pain is from the residual condition of the patella.' the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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: NO 4 TRIATH TS PLUS TIB INS X3 POLY 19MM
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21795493
• Report Number: 0002249697-2025-00389
• Device Sequence Number: 15395683
• Product Code: MBH
• UDI-Device Identifier: 07613327287714
• UDI-Public: 07613327287714
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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 Expiration Date: 11/30/2024
• Device Catalogue Number: 5537-G-419-E
• Device Lot Number: HM32YL
• 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: 03/17/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 04/08/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2019
• 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: Other
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White