MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 7 TRIATH TS PLUS TIB INS X3 POLY 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-716
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Fibrosis (3167)
Date of Event	07/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding arthrofibrosis 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 remained implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: confirmation of event: i can confirm that the patient had a primary right total knee arthroplasty since i was able to see an x-ray with the implant in place.I can also confirm that the patient underwent an incision and drainage and manipulation of the knee, as well as a revision total knee arthroplasty of that same knee due to mechanical loosening since i was able to review the operation reports.Root cause analysis: the root cause of these events cannot be determined with certainty.The patient apparently developed loosening of a primary total knee arthroplasty as well as a hematoma and arthrofibrosis and eventually required revision surgery.The causes of these events are multifactorial including surgical technique, patient factors including lifestyle, activity level and bmi.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: it was reported that the patient had a mua (manipulation under anesthesia) due to arthrofibrosis.A review of the provided medical records by a clinical consultant indicated: confirmation of event: i can confirm that the patient had a primary right total knee arthroplasty since i was able to see an x-ray with the implant in place.I can also confirm that the patient underwent an incision and drainage and manipulation of the knee, as well as a revision total knee arthroplasty of that same knee due to mechanical loosening since i was able to review the operation reports.Root cause analysis: the root cause of these events cannot be determined with certainty.The patient apparently developed loosening of a primary total knee arthroplasty as well as a hematoma and arthrofibrosis and eventually required revision surgery.The causes of these events are multifactorial including surgical technique, patient factors including lifestyle, activity level and bmi.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.
Event or Problem Description
The following was reported: "subject was enrolled in the 76-triathlon® cones augment study (revision study) on (b)(6) 2018; subject had a draining wound hematoma and arthrofibrosis (rom-0-60°) and went to or on (b)(6) 2018 for and i/d and mua.All available information from the facility is provided.".

• Brand Name: NO 7 TRIATH TS PLUS TIB INS X3 POLY 16MM
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 22095657
• Report Number: 0002249697-2025-00554
• Device Sequence Number: 15182693
• Product Code: MBH
• UDI-Device Identifier: 07613327027495
• UDI-Public: 07613327027495
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2025

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: 02/29/2020
• Device Catalogue Number: 5537-G-716
• Device Lot Number: 740N30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2015
• 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: Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American