MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #4 CS ALLPOLY 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5534A409
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	10/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
This mdr is for the irrigation and debridement (no revision).Left knee.Subject was enrolled in study.Subject contacted site by phone to report sudden onset of pain; clinic visit aspiration was positive for staph epidermidis and subject was taken to or for i/d and start of long-term antibiotic therapy receiving ancef, vancomycin and doxycycline.Subject reported pain and joint was aspirated.Culture was positive for doxycycline resistant strain of staph and taken to surgery for revision.During this hospitalization subject had complications of circulatory shock, acute kidney injury and liver failure resulting in death.
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.The following devices were also listed in this report: triathlon cr fem comp #4 l-cem; cat# 5510f401; lot# h479r.Triathlon asym patella a32x10 ; cat# 5551l320; lot# ljk377.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving a triathlon insert was reported.The event was 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 with a clinical consultant indicated "confirmation of event: i can confirm that the patient had the primary knee replacement, the incision and drainage and irrigation and debridement, as well as the re-implantation procedure since i was able to review operation reports and medical records root cause analysis: the root cause of these events cannot be determined with certainty.The causes of postoperative joint infection are multifactorial including surgical technique, operating room environment, patient factors including the patient's own microbiome and the patients general health.Spread from a remote site with bacteria can occur and cause a periprosthetic infection.This patient was morbidly obese which also contributes to an increased risk of infection.As to the cardiac arrhythmia, this is a medical condition that once it happens, at times it is not correctable and the patient does not survive, as with what happened in this case.I would not assign any causality of these events to the implant itself.-product 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 1 other similar events for the lot and sterile lot referenced however it relates to the same device and patient.Conclusions: all stryker products are sold as sterile either by being validated to a minimum sterility assurance level sal of 10^-6 or aseptically filled under a validated process in accordance with applicable external standards.A review with a clinical consultant indicated "confirmation of event: i can confirm that the patient had the primary knee replacement, the incision and drainage and irrigation and debridement, as well as the re-implantation procedure since i was able to review operation reports and medical records root cause analysis: the root cause of these events cannot be determined with certainty.The causes of postoperative joint infection are multifactorial including surgical technique, operating room environment, patient factors including the patient's own microbiome and the patients general health.Spread from a remote site with bacteria can occur and cause a periprosthetic infection.This patient was morbidly obese which also contributes to an increased risk of infection.As to the cardiac arrhythmia, this is a medical condition that once it happens, at times it is not correctable and the patient does not survive, as with what happened in this case.I would not assign any causality of these events to 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 #4 CS ALLPOLY 9MM
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23644438
• Report Number: 0002249697-2025-01381
• Device Sequence Number: 18553393
• Product Code: MBH
• UDI-Device Identifier: 07613327043259
• UDI-Public: 07613327043259
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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: 04/30/2024
• Device Catalogue Number: 5534A409
• Device Lot Number: 451617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2019
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 126 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White