MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531G416
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	11/01/2022
Type of Reportable Event	Serious Injury
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: unknown right knee baseplate; cat and lot # unknown, unknown right knee femoral component; cat and 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
Patient reported continued pain and swelling after revision.
Additional Manufacturer Narrative
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: "this patient underwent a primary cementless cruciate retaining total knee arthroplasty in may 2021.In november 2021 the patient underwent a revision for pain, swelling and instability with the tibial component being oversized.The tibial component was replaced and a thicker polyethylene was utilized.I can confirm that the primary and revision procedure took place since i was able to review the operation reports.I have no x-rays so i cannot determine whether the tibial component was indeed oversized or not.The root cause of these events cannot be determined with absolute certainty.The causes of early revision for pain swelling and instability are multifactorial but almost always involves surgical technique, especially in the choice of implants, positioning and kinematic restoration and ligament balance.Remotely, patient factors can contribute including activity level and bmi and whether or not trauma occurred.In this case no trauma was noted.I would not assign any causality to the implant itself.However the explanted prostheses should be submitted to stryker for evaluation and examination.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 is experiencing pain and swelling after revision.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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.The following devices were also listed in this report: tri ts baseplate size 4; cat# 5521-b-400; lot# unknown.Tri cemented stem 12mmx100mm; cat# ;5560-s-212 lot# unknown.Triathlon p/a cr beaded #6r; cat# 5517f602; lot# unknown.Tritanium patella-asymmetric; cat# 5552-l-350; 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
Patient reported continued pain and swelling after revision.
Additional Manufacturer Narrative
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: "this patient underwent a primary cementless cruciate retaining total knee arthroplasty in (b)(6) 2021.In (b)(6) 2021 the patient underwent a revision for pain, swelling and instability with the tibial component being oversized.The tibial component was replaced and a thicker polyethylene was utilized.I can confirm that the primary and revision procedure took place since i was able to review the operation reports.I have no x-rays so i cannot determine whether the tibial component was indeed oversized or not.The root cause of these events cannot be determined with absolute certainty.The causes of early revision for pain swelling and instability are multifactorial but almost always involves surgical technique, especially in the choice of implants, positioning and kinematic restoration and ligament balance.Remotely, patient factors can contribute including activity level and bmi and whether or not trauma occurred.In this case no trauma was noted.I would not assign any causality to the implant itself.However the explanted prostheses should be submitted to stryker for evaluation and examination.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 is experiencing pain and swelling after revision.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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.The following devices were also listed in this report: tri ts baseplate size 4; cat# 5521-b-400; lot# hyv7ba.Tri cemented stem 12mmx100mm; cat# ;5560-s-212 lot# 0113135k.Triathlon p/a cr beaded #6r; cat# 5517f602; lot# jt26c.Tritanium patella-asymmetric; cat# 5552-l-350; lot# naym1.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Patient reported continued pain and swelling after revision.

• Brand Name: X3 TRIATHLON CS INS SIZE4 16MM
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17486130
• Report Number: 0002249697-2023-00880
• Device Sequence Number: 7246502
• Product Code: MBH
• UDI-Device Identifier: 07613327045833
• UDI-Public: 07613327045833
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2024

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: 5531G416
• Device Lot Number: LHQ638
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 12/19/2023; 08/13/2024
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 01/10/2024; 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2022
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 93 KG