MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #6 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5531-G-609-E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 04/07/2023

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: triathlon p/a cr beaded #7r; cat# 5517f702; lot# nyr9r.Tritanium bplate triathlon s6; cat# 5536b600; lot# ctd50018.Tritanium patella-asymmetric; cat# 5552-l-381; lot# th1d1.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.

Event Description

Patient reported via mako stryker page: "please help.Had a mako total knee 8 months ago & unfortunately, it has been a failure: swelling, stiffness, pain going down stairs & challenging going upstairs.Am in need of a 3rd opinion recommendation.So disappointed & discouraged.Help & thank you.".

Manufacturer Narrative

Reported event: an event regarding rom involving a triathlon insert was reported.The event was confirmed via clinician review of the provided medical records.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 information by a clinical consultant indicated: "this patient underwent a primary mako assisted cementless total knee arthroplasty in (b)(6) 2022 and has not done well.He continues to complain of pain swelling stiffness and difficulty with walking and going up downstairs and normal activities of daily living.An arthroscopic procedure has been suggested to help determine the cause of is difficulty.I can confirm that this patient had a primary right total knee arthroplasty since i was able to review his operation report.The root cause of this patient's difficulties cannot be determined with certainty.The causes of pain swelling stiffness, difficulty with going up and down stairs, etc.At eight months following surgery are multifactorial including surgical technique, patient factors including activity level and bmi, the possibility of arthrofibrosis and possible infection can also be considered.Based upon the information provided i would not assign any causality to the implant itself.Review of pre op and post op xrays would be helpful in assessing the inquiry." -product history review: review of the device history records indicate the 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 stiffness, pain, and swelling post-implantation.A review of the provided medical records by a clinician confirmed the patient's experience but was unable to determine a root cause: "the causes of pain swelling stiffness, difficulty with going up and down stairs, etc.At eight months following surgery are multifactorial including surgical technique, patient factors including activity level and bmi, the possibility of arthrofibrosis and possible infection can also be considered.Based upon the information provided i would not assign any causality to the implant itself.Review of pre op and post op xrays would be helpful in assessing the inquiry." 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 Description

Patient reported via mako stryker page: "please help.Had a mako total knee 8 months ago & unfortunately, it has been a failure: swelling, stiffness, pain going down stairs & challenging going upstairs.Am in need of a 3rd opinion recommendation.So disappointed & discouraged.Help & thank you".

• Brand Name: X3 TRIATHLON CS INSERT #6 9MM
• Type of Device: 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: 16853011
• MDR Text Key: 314371477
• Report Number: 0002249697-2023-00462
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327337402
• UDI-Public: 07613327337402
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5531-G-609-E
• Device Catalogue Number: 5531-G-609-E
• Device Lot Number: RP47NE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 95 KG