MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5510F502
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/14/2025
Type of Reportable Event	Serious Injury
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 other 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.
Event or Problem Description
Right total knee.The patient had an infection in this knee prior to the index surgery.Due to the infection the implants in the index case were loosely cemented with the intent of clearing the infection and being revised to definitive implants.A stem was added to the tibial component to add stability to this construct.Subsequently the patient fell and fractured their distal femur.The revision today was performed to address the fracture.Preop cultures were negative for infection.No further information is available from the doctor or hospital.
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.-clinical review: a review of the provided medical records by a clinical consultant indicated: "the x-rays document a comminuted highly displaced supracondylar periprosthetic fracture above a tka.No documentation was provided to determine the root cause of this complication nor the reported infection of the index knee.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 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: "the x-rays document a comminuted highly displaced supracondylar periprosthetic fracture above a tka.No documentation was provided to determine the root cause of this complication nor the reported infection of the index knee.Should further documentation become available i would be happy to further this investigation." 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.
Event or Problem Description
Right total knee.The patient had an infection in this knee prior to the index surgery.Due to the infection the implants in the index case were loosely cemented with the intent of clearing the infection and being revised to definitive implants.A stem was added to the tibial component to add stability to this construct.Subsequently the patient fell and fractured their distal femur.The revision today was performed to address the fracture.Preop cultures were negative for infection.No further information is available from the doctor or hospital.

• Brand Name: TRIATHLON CR FEM COMP #5 R-CEM
• 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 NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 21343165
• Report Number: 0002249697-2025-00184
• Device Sequence Number: 13001721
• Product Code: MBH
• UDI-Device Identifier: 07613327040302
• UDI-Public: 07613327040302
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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: 5510F502
• Device Lot Number: JL63U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2024
• 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: 64 YR
• Patient Sex: Male