MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5515-F-402
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient's right knee was revised due to periprosthetic fracture.A ps knee was converted to a triathlon hinge knee.No other information available due to hospital policy.Nov 26, 2024- as per medical review: on ap view one can see that there is a periprosthetic fracture just above the femoral prosthesis.It is displaced medially.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving a triathlon femoral component 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.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient underwent a right total knee arthroplasty with aps femoral component, cemented patella and cemented tibial baseplate with a stem extension and a ts polyethylene insert, since i was able to see an x-ray with the implant in place.I can also confirm the periprosthetic fracture all since i was able to see the fracture on that same x-ray.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of femoral periprosthetic fracture less than one month postoperative are multifactorial.Causes include trauma, but in this case, there was no history of trauma.Causes also include surgical technique in the way the implants are inserted and how the bone is prepared.Unrecognized fissures can lead to fracture.Bone quality also is a factor.This implant utilized a posteriorly stabilized femur without a stem and had a total stabilized tibial insert.That can lead to increased stress above the femoral component which could lead to fracture especially if the bone quality is poor.The patient's lifestyle, activity level and bmi can also contribute.I would not assign any causality to the implant itself." 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 has been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to a femoral periprosthetic fracture.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient underwent a right total knee arthroplasty with aps femoral component, cemented patella and cemented tibial baseplate with a stem extension and a ts polyethylene insert, since i was able to see an x-ray with the implant in place.I can also confirm the periprosthetic fracture all since i was able to see the fracture on that same x-ray.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of femoral periprosthetic fracture less than one month postoperative are multifactorial.Causes include trauma, but in this case, there was no history of trauma.Causes also include surgical technique in the way the implants are inserted and how the bone is prepared.Unrecognized fissures can lead to fracture.Bone quality also is a factor.This implant utilized a posteriorly stabilized femur without a stem and had a total stabilized tibial insert.That can lead to increased stress above the femoral component which could lead to fracture especially if the bone quality is poor.The patient's lifestyle, activity level and bmi can also contribute.I would not assign any causality to the implant itself." 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 FEM COMPONENT CEMENTED
• 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: 20830507
• Report Number: 0002249697-2024-01663
• Device Sequence Number: 3863169
• Product Code: MBH
• UDI-Device Identifier: 07613327050370
• UDI-Public: 07613327050370
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K042993
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/03/2024

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: 5515-F-402
• Device Lot Number: L4D4IL7L4T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Female