MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531G413E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding pain involving a triathlon insert 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 that the patient had a primary cementless cruciate retaining triathlon totally arthroplasty since i was able to review the operation report.I can also confirm that the patient underwent a revision of that implant, also because i was able to review the operation report.Root cause analysis: the root cause of this event cannot be determined with certainty.Causes of postoperative instability with synovitis and tightness of the pcl in flexion, and ligamentous laxity medially and lateral knee are multifactorial.The medial and lateral ligaments certainly can stretch out postoperatively but at about one year postoperative it is a bit unusual to be non-iatrogenic.Usually when ligaments stretch out, without trauma, it takes a few years.The surgeon stated that the pcl was tight in flexion and most likely this was present postoperatively.The femoral component is positioned a bit posteriorly and this may affect the kinematics of the knee as well.I do not believe that patient factors including lifestyle, activity level and bmi play a role here.I would not assign any causality to the implants themselves." -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 was revised due to instability.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a primary cementless cruciate retaining triathlon totally arthroplasty since i was able to review the operation report.I can also confirm that the patient underwent a revision of that implant, also because i was able to review the operation report.Root cause analysis: the root cause of this event cannot be determined with certainty.Causes of postoperative instability with synovitis and tightness of the pcl in flexion, and ligamentous laxity medially and lateral knee are multifactorial.The medial and lateral ligaments certainly can stretch out postoperatively but at about one year postoperative it is a bit unusual to be non-iatrogenic.Usually when ligaments stretch out, without trauma, it takes a few years.The surgeon stated that the pcl was tight in flexion and most likely this was present postoperatively.The femoral component is positioned a bit posteriorly and this may affect the kinematics of the knee as well.I do not believe that patient factors including lifestyle, activity level and bmi play a role here.I would not assign any causality to the implants themselves." based on the device information, it has been determined that this device is not in scope of a recall.No further investigation for this event is possible at this time.If additional information/device become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Pt.Reported they continued experiencing pain, and swelling.On anti inflammatory medication for pain.

• Brand Name: X3 TRIATHLON CS INS SIZE4 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-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20521558
• Report Number: 0002249697-2024-01456
• Device Sequence Number: 7880396
• Product Code: MBH
• UDI-Device Identifier: 07613327337396
• UDI-Public: 07613327337396
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2024

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: 5531G413E
• Device Lot Number: N27WJ3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2023
• 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: Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian