MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER

Catalog Number	5532-G-513
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Arthrofibrosis (4885)
Date of Event	07/22/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: based on medical records, postop right tka progress notes on (b)(6) 2015, the patient stated "she started having lateral knee pain on the right knee.Assessment: scar tissue over the right knee.Plan: we asked her to massage it or do hot tub, whirlpool, bathing, or a heating pad in order to break up the scar.We also discussed that if it does not get better, we may try to do a course of injections in order to decrease the amount of scar.Surgical options would be for arthroscopic debridement.".
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.The following devices were also listed in this report: cat# 5516f502; triathlon p/a ps beaded #5r; lot# unknown, cat# 5536b500; tritanium bplate triathlon s5lot# 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
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding arthrofibrosis 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 was not returned.Clinician review: a review of the provided medical records associated with pi 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." device history review: could not be performed as lot code information was unknown.Complaint history review: could not be performed as lot code information was unknown.Conclusion: 'based on medical records in pi, postop right tka progress notes on (b)(6) 2015, the patient stated "she started having lateral knee pain on the right knee.[.] assessment : [.] scar tissue over the right knee.Plan: [.] we asked her to massage it or do hot tub, whirlpool, bathing, or a heating pad in order to break up the scar.We also discussed that if it does not get better, we may try to do a course of injections in order to decrease the amount of scar.Surgical options would be for arthroscopic debridement." the exact cause of the event could not be determined because insufficient information was provided.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER
• 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, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 23336067
• Report Number: 0002249697-2025-01141
• Device Sequence Number: 7808275
• Product Code: JWH
• UDI-Device Identifier: 07613327050790
• UDI-Public: 07613327050790
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K242831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: 09/22/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 02/19/2026
• 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: Required Intervention; Hospitalization
• Patient Sex: Female