MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON ASYMMETRIC X3 PATELLA; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	5551-G-350-E
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	10/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
A triathlon ts knee with stems and augments was implanted on (b)(6) 2020.As of (b)(6) 2021, the following were noted: "patient fell in (b)(6) (2021) and subsequently injured her knee and will need her patellar revised in the future." in (b)(6) 2021, patellar loosening was cited.On (b)(6) 2021, loosening of the tibia was also noted.As of (b)(6) 2021, the patient has not been revised due to patient factors.
Additional Manufacturer Narrative
Reported event: an event regarding loosening 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 remains implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: i can confirm the patient had a cemented triathlon implant with a cr femoral component, a cemented patella component and a cemented tibial component with a long stem extension since i was able to review the x-rays.I can also confirm that the patient underwent a revision with a triathlon ts implant with augments and a tibial cone since i was able to review x-rays with that implant construct in place.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of loosening of all three components of a total knee arthroplasty at three years are multifactorial.The causes include surgical technique especially in the positioning of the components, restoration of kinematics the knee and cement technique.Other causes such as infection could be considered, although there was no mention of infection in this particular case.Other contributing factors include patient factors such as lifestyle, activity level, and bmi.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 is experiencing pain due to loosening.A review of the provided medical records by a clinical consultant indicated: i can confirm the patient had a cemented triathlon implant with a cr femoral component, a cemented patella component and a cemented tibial component with a long stem extension since i was able to review the x-rays.I can also confirm that the patient underwent a revision with a triathlon ts implant with augments and a tibial cone since i was able to review x-rays with that implant construct in place.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of loosening of all three components of a total knee arthroplasty at three years are multifactorial.The causes include surgical technique especially in the positioning of the components, restoration of kinematics the knee and cement technique.Other causes such as infection could be considered, although there was no mention of infection in this particular case.Other contributing factors include patient factors such as lifestyle, activity level, and bmi.I would not assign any causality 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
A triathlon ts knee with stems and augments was implanted on (b)(6) 2020.As of 22/october/2021, the following were noted: "patient fell in (b)(6) (2021) and subsequently injured her knee and will need her patellar revised in the future." in (b)(6) 2021, patellar loosening was cited.On (b)(6) 2021, loosening of the tibia was also noted.As of (b)(6) 2021, the patient has not been revised due to patient factors.

• Brand Name: TRIATHLON ASYMMETRIC X3 PATELLA
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 20559755
• Report Number: 0002249697-2024-01481
• Device Sequence Number: 16956605
• Product Code: JWH
• UDI-Device Identifier: 07613327314793
• UDI-Public: 07613327314793
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• 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): 12/03/2024

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: 01/31/2025
• Device Catalogue Number: 5551-G-350-E
• Device Lot Number: N26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2020
• 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: Female
• Patient Weight: 102 KG