MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT NO 5 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531-G-509-E
Medical Device Problem Codes	Unstable (1667); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
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.H3 other text : device not returned to the manufacturer.
Event or Problem Description
It was reported through the stryker facebook page, "i had my tkr on (b)(6) and i'm still in pain, have clunking in my knee, swelling is still present, i am doing ok, walking is fine, pt is going good i guess, its disappointing to me that im this long into it and still feel like i do? everyone heals differently" additional fb comment, "9 weeks in and still have stiffness and pain, clicking while walking, i'm really disappointed right now, hope and pray things start to get better, can't stay out of work much longer, getting frustrated.".
Event or Problem Description
It was reported through the stryker facebook page, "i had my tkr on october 4th and i'm still in pain, have clunking in my knee, swelling is still present, i am doing ok, walking is fine, pt is going good i guess, its disappointing to me that im this long into it and still feel like i do? everyone heals differently" additional fb comment, "9 weeks in and still have stiffness and pain, clicking while walking, i'm really disappointed right now, hope and pray things start to get better, can't stay out of work much longer, getting frustrated" additional fb comment, "update: had total knee replacement on oct 4th.First off, still feels like something wasn't tightened up enough, feels loose and clunky, secondly, pain is starting to become much more tolerable with pt, but still no improvement with the clunking, i'm starting to feel like it needs to be redone? i'm going to stay optimistic, but i can also not ignore how it feels" additional fb comment, "please forward your contact information, i am having complications with my triathlon full knee replacement and i need advice on how to resolve this issue, thank you" update per conversation with patient 05-jan-2024: patient reported continuous ¿clunking and loose feeling and pain¿.Patient noted he is not capable of going back to work.
Additional Manufacturer Narrative
A3a - patient sex corrected from f to m an event regarding instability 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 of medical records with a clinical consultant indicated "conclusion/assessment: a patient underwent a tka in (b)(6) 2023.It is unclear why they underwent the procedure as it was stated that the patient did not perceive a need for a tka.Preoperative radiographs were not provided for review.The procedure was performed with the robot but no intraoperative or hospital records were provided for review.The patient was unhappy with a clunking feeling and swelling in the knee.While the reports state that there was no feeling of instability this is not consistent with the patient complaints and symptoms.Apparently, polyethylene exchange was discussed to tighten up the knee.Event confirmation: a tka can be confirmed.Patient complains of clunking and likely instability can be confirmed.Root cause: the root cause of the patient complaint appears to be varus valgus instability.Poor patient preoperative preparation and evaluation may have contributed to the patient dissatisfaction.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: a review of medical records with a clinical consultant indicated "conclusion/assessment: a patient underwent a tka in (b)(6) 2023.It is unclear why they underwent the procedure as it was stated that the patient did not perceive a need for a tka.Preoperative radiographs were not provided for review.The procedure was performed with the robot but no intraoperative or hospital records were provided for review.The patient was unhappy with a clunking feeling and swelling in the knee.While the reports state that there was no feeling of instability this is not consistent with the patient complaints and symptoms.Apparently, polyethylene exchange was discussed to tighten up the knee.Event confirmation: a tka can be confirmed.Patient complains of clunking and likely instability can be confirmed.Root cause: the root cause of the patient complaint appears to be varus valgus instability.Poor patient preoperative preparation and evaluation may have contributed to the patient dissatisfaction.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.The following devices were also listed in this report: cat# 5510f502; triathlon cr fem comp #5 r-cem; lot# rhu6u cat# 5521-b-500; tri ts baseplate size 5; lot# odt3la cat# 6197-9-001; simplex p with tobramycin 1 pack; lot# mfe056 qty (b)(4) 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 INSERT NO 5 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18309577
• Report Number: 0002249697-2023-01543
• Device Sequence Number: 15104259
• Product Code: MBH
• UDI-Device Identifier: 07613327336511
• UDI-Public: 07613327336511
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

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 Catalogue Number: 5531-G-509-E
• Device Lot Number: D8160X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2023
• 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; Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 107 KG