MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5532-G-513
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As part of an investigator initiated study, a spreadsheet was provided indicating that the patient's right knee was revised due to global instability.The femoral component, baseplate and liner were revised (patella was retained).
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.The following devices were also listed in this report: triathlon p/a ps beaded #5r; cat# 5516f502; lot# unknown tritanium bplate triathlon s5; cat# 5536b500; lot# unknown it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Update on 15 sep 2022 based on medical records: "right total knee arthroplasty revision procedure note (b)(6) 2022 [.] radiographs demonstrated suboptimal positioning of her components with flexion of her femoral component.
Additional Manufacturer Narrative
Reported event: an event regarding instability involving a triathlon insert was reported.The event was confirmed via medical review.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: "confirmation of event: i can confirm that the patient had the primary total knee arthroplasty since i was able to review the operation report.I can also confirm that the patient underwent a revision procedure by another surgeon using competitor implants also since i was able to review the revision operation report.Root cause analysis: the root cause of this event cannot be determined with certainty.Causes of global instability of a total knee arthroplasty nine years after implantation are multifactorial.These include the initial surgical technique regarding ligament balance, and restoration of alignment, position and kinematics of the knee.Patient factors also contribute, including lifestyle, activity level, and bmi.Although instability can be a result of polyethylene wear, with the information provided there is no evidence of this.Therefore, i would not assign any causality to the implant itself." -product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to instability.The event was confirmed via medical review.The root cause of this event cannot be determined with certainty.As clinician indicated, "causes of global instability of a total knee arthroplasty nine years after implantation are multifactorial.These include the initial surgical technique regarding ligament balance, and restoration of alignment, position and kinematics of the knee.Patient factors also contribute, including lifestyle, activity level, and bmi.Although instability can be a result of polyethylene wear, with the information provided there is no evidence of this." no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22434616
• Report Number: 0002249697-2025-00663
• Device Sequence Number: 3152499
• Product Code: MBH
• UDI-Device Identifier: 07613327050790
• UDI-Public: 07613327050790
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: 5532-G-513
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Race: White