MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE6 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-613-E
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	10/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via patient letter: ".I underwent total knee replacement (tkr) of my left knee on (b)(6) 2021.The device used for my tkr was the stryker triathlon cementless cruciate-retaining total knee prosthesis.I have been diagnosed with flexion instability of greater than 10mm of anterior/ posterior excursion as 90 degrees flexion.Both doctors stated that physical therapy would not alleviate my flexion instability, chronic inflammation, and pain.Both doctors stated that revision tkr surgery would be necessary.Is stryker working on any sort of solution to flexion instability associated with tkr with the stryker triathlon prosthesis short of revision tkr? how common is flexion instability following tkr with the stryker tkr with the stryker triathlon prosthesis? what could have caused the flexion instability? what actions (doctor training, better guidance, etc) is stryker taking to avoid flexion instability in future tkr surgeries? the thought of having to endure revision tkr is not very appealing.If there is some sort of other solution to flexion instability associated with the stryker triathlon prosthesis, please contact me.".
Additional Manufacturer Narrative
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
As reported via patient letter: ".I underwent total knee replacement (tkr) of my left knee on (b)(6) 2021.The device used for my tkr was the stryker triathlon cementless cruciate-retaining total knee prosthesis.I have been diagnosed with flexion instability of greater than 10mm of anterior/ posterior excursion as 90 degrees flexion.Both doctors stated that physical therapy would not alleviate my flexion instability, chronic inflammation, and pain.Both doctors stated that revision tkr surgery would be necessary.Is stryker working on any sort of solution to flexion instability associated with tkr with the stryker triathlon prosthesis short of revision tkr? how common is flexion instability following tkr with the stryker tkr with the stryker triathlon prosthesis? what could have caused the flexion instability? what actions (doctor training, better guidance, etc) is stryker taking to avoid flexion instability in future tkr surgeries? the thought of having to endure revision tkr is not very appealing.If there is some sort of other solution to flexion instability associated with the stryker triathlon prosthesis, please contact me.".
Additional Manufacturer Narrative
An event regarding instability involving a triathlon insert was reported.The event was confirmed via clinician review of the provided medical records.Method & results: device 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: conclusion of assessment: patient dissatisfaction with uncemented cr triathlon knee due to symptomatic and clinically diagnosed flexion instability.Root cause and confirmation: a root cause cannot be ascertained from the information provided but there is no reason to attribute the complaint to the implants.Device 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.Conclusion: a review of the provided medical records by a clinical consultant indicated: conclusion of assessment: patient dissatisfaction with uncemented cr triathlon knee due to symptomatic and clinically diagnosed flexion instability.Root cause and confirmation: a root cause cannot be ascertained from the information provided but there is no reason to attribute the complaint to the implants.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.The following devices were also listed in this report: cat# 5517f701; triathlon p/a cr beaded #7l; lot# jly9h; cat# 5536b600; tritanium bplate triathlon s6; lot# ctd56997; cat# 5552-l-401; tritanium patella-asymmetric; lot# nhyd1.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: X3 TRIATHLON CS INS SIZE6 13MM
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15767422
• Report Number: 0002249697-2022-01600
• Device Sequence Number: 14685518
• Product Code: MBH
• UDI-Device Identifier: 07613327337761
• UDI-Public: 07613327337761
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2023

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: 02/28/2026
• Device Model Number: 5531-G-613-E
• Device Catalogue Number: 5531-G-613-E
• Device Lot Number: 4M2HPJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2021
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 108 KG