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-609-E
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Arthrofibrosis (4885)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Pt.Reports revision due to stiffness and pain in right knee.Pt.Requests a recall inquiry.Pt.States they still have the original implants in place.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no similar events for the lot referenced.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: 5552-l-350, tritanium patella-asymmetric, 1, u38u1; 5520-b-600, triathlon prim tib bplate cemented sz 6, 1, lyg3gb; 5516-f-702, triathlon p/a ps beaded #7r, 1, lcl4c.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
An event regarding range of motion (rom) 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 was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: "the records indicate the patient underwent an uncomplicated mako assisted right tka on 6/21/23.He unfortunately developed arthrofibrosis resulting in a stiff painful knee.His index surgeon returned him to the operating room in october 2023 for an arthroscopic lysis of adhesions in this knee.Unfortunately, this failed to resolve this problem.He was subsequently seen by another surgeon who performed an extensive workup.Infection and loss of fixation were ruled out.After further attempts of conservative management did not have any resulting improvement, he underwent an open synovectomy and synovial biopsy.He had some improvement post-operatively with arom of -5 to 105.Post tka arthrofibrosis is confirmed.The root cause of this arthrofibrosis cannot be determined from the documentation provided.Should further documentation become available i would be happy to further this investigation.-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 had revision due to rom.A review of the provided medical records by a clinical consultant indicated: "the records indicate the patient underwent an uncomplicated mako assisted right tka on 6/21/23.He unfortunately developed arthrofibrosis resulting in a stiff painful knee.His index surgeon returned him to the operating room in october 2023 for an arthroscopic lysis of adhesions in this knee.Unfortunately, this failed to resolve this problem.He was subsequently seen by another surgeon who performed an extensive workup.Infection and loss of fixation were ruled out.After further attempts of conservative management did not have any resulting improvement, he underwent an open synovectomy and synovial biopsy.He had some improvement post-operatively with arom of -5 to 105.Post tka arthrofibrosis is confirmed.The root cause of this arthrofibrosis cannot be determined from the documentation provided.Should further documentation become available i would be happy to further this investigation.The patient also inquires if the device is scope of a recall, no recall is associated with this device.Also, no further investigation is possible at this time.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
An event regarding arthrofibrosis 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 was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: "the records indicate the patient underwent an uncomplicated mako assisted right tka on (b)(6) 2023.He unfortunately developed arthrofibrosis resulting in a stiff painful knee.His index surgeon returned him to the operating room in october 2023 for an arthroscopic lysis of adhesions in this knee.Unfortunately, this failed to resolve this problem.He was subsequently seen by another surgeon who performed an extensive workup.Infection and loss of fixation were ruled out.After further attempts of conservative management did not have any resulting improvement, he underwent an open synovectomy and synovial biopsy.He had some improvent post-operatively with arom of -5 to 105.Post tka arthrofibrosis is confirmed.The root cause of this arthrofibrosis cannot be determined from the documentation provided.Should further documentation become available i would be happy to further this investigation.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 had revision due to rom.A review of the provided medical records by a clinical consultant indicated: "the records indicate the patient underwent an uncomplicated mako assisted right tka on (b)(6) 2023.He unfortunately developed arthrofibrosis resulting in a stiff painful knee.His index surgeon returned him to the operating room in october 2023 for an arthroscopic lysis of adhesions in this knee.Unfortunately, this failed to resolve this problem.He was subsequently seen by another surgeon who performed an extensive workup.Infection and loss of fixation were ruled out.After further attempts of conservative management did not have any resulting improvement, he underwent an open synovectomy and synovial biopsy.He had some improvent post-operatively with arom of -5 to 105.Post tka arthrofibrosis is confirmed.The root cause of this arthrofibrosis cannot be determined from the documentation provided.Should further documentation become available i would be happy to further this investigation.The patient also inquires if the device is scope of a recall, no recall is associated with this device.Also, no further investigation is possible at this time.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, 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 NJ NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21503575
• Report Number: 0002249697-2025-00255
• Device Sequence Number: 19933452
• Product Code: MBH
• UDI-Device Identifier: 07613327338096
• UDI-Public: 07613327338096
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 07/15/2025

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-609-E
• Device Lot Number: 7K34EJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 05/09/2025; 06/19/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 06/04/2025; 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2023
• 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
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 48 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White