MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #2L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5517-F-201
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Patient presented to clinic with pain discomfort and fx triathlon femoral implant.Anterior trochlear portion med to lateral fracture of metal femur.Revision knee surgery not scheduled.
Event or Problem Description
Patient presented to clinic with pain discomfort and fx triathlon femoral implant.Anterior trochlear portion med to lateral fracture of metal femur.Revision knee surgery not scheduled.Update: patient was revised."revision knee surgery left femoral component with secondary fx of femur with patella involvement".
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon femoral component was reported.The event was confirmed via evaluation of the returned device.Method & results: -product evaluation and results: visual inspection: visual inspection was performed as part of the material analysis: "image shows the triathlon femoral component with fracture location highlighted by the arrow.Also shown in the image is the tritanium patella.On visual examination, the fracture was observed on the medial condyle towards the anterior tip.The surface of the patella femoral component showed evidence of wear and explantation damage.Material analysis: a material analysis was performed and concluded the following: "review of triathlon p/a cr beaded #2l, catalogue # 5517-f-201, lot code jpc3h confirmed a fracture on the medial condyle towards the anterior tip.Characterisation using stereo microscopy, scanning electron microscopy and eds identified burnishing on the medial condyle and wear on patella, indicating contact between the medial condyle and the patella post fracture.Stereo microscopy confirmed the presence of peri-apatite coating and bone growth on the anterior region of the beaded surface.The fracture propagated in fatigue as indicated by the typical fatigue striations observed near the fracture origin of the femoral component.An area of shrinkage / incipient melting was observed near the fracture origin." -clinician review: a review of the provided medical information by a clinical consultant indicated: "this inquiry concerns a patient who underwent a primary cementless total knee arthroplasty and then 15 months later sustained a fracture of the femoral component.No meaningful history is given, as to whether the patient had trauma, an accident, etc.No preoperative x-rays, immediate postop x-rays from her primary procedure or follow-up x-rays after her revision procedure are provided.Only one ap view of the alleged fracture is provided.Regarding the root cause of this event, i would need more information in order to assess this.Fracture of a femoral component that is well fixed is unusual and in fact, this is the first case of a triathlon beaded p/a component i have seen or know of personally.Causes of implant fracture are multifactorial including abnormal stress forces due to a well fixed implant in some places and lack of fixation in others, surgical technique factors and patient activity factors such as bmi and activity level.A defect in an implant can also lead to failure." -product history review: review of the device history records indicate the 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 was revised due to fracture of the femoral component.The device was returned for evaluation.A material analysis was performed and concluded the following: "review of triathlon p/a cr beaded #2l, catalogue # 5517-f-201, lot code jpc3h confirmed a fracture on the medial condyle towards the anterior tip.Characterisation using stereo microscopy, scanning electron microscopy and eds identified burnishing on the medial condyle and wear on patella, indicating contact between the medial condyle and the patella post fracture.Stereo microscopy confirmed the presence of peri-apatite coating and bone growth on the anterior region of the beaded surface.The fracture propagated in fatigue as indicated by the typical fatigue striations observed near the fracture origin of the femoral component.An area of shrinkage / incipient melting was observed near the fracture origin." a review of the provided medical information by a clinical consultant indicated: "this inquiry concerns a patient who underwent a primary cementless total knee arthroplasty and then 15 months later sustained a fracture of the femoral component.No meaningful history is given, as to whether the patient had trauma, an accident, etc.No preoperative x-rays, immediate postop x-rays from her primary procedure or follow-up x-rays after her revision procedure are provided.Only one ap view of the alleged fracture is provided.Regarding the root cause of this event, i would need more information in order to assess this.Fracture of a femoral component that is well fixed is unusual and in fact, this is the first case of a triathlon beaded p/a component i have seen or know of personally.Causes of implant fracture are multifactorial including abnormal stress forces due to a well fixed implant in some places and lack of fixation in others, surgical technique factors and patient activity factors such as bmi and activity level." the exact cause of the event could not be determined from the information provided.Additional information such as serial x-rays, the primary and revision operation reports, patient history and follow-up notes are needed to further investigate root cause.There is no indication at this time that the reported event is the result of a manufacturing issue.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 P/A CR BEADED #2L
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14186350
• Report Number: 0002249697-2022-00578
• Device Sequence Number: 5908666
• Product Code: MBH
• UDI-Device Identifier: 07613327040906
• UDI-Public: 07613327040906
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2022

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 Expiration Date: 01/31/2025
• Device Model Number: 5517-F-201
• Device Catalogue Number: 5517F201
• Device Lot Number: JPC3H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2020
• 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; Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female