MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #7; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5520-B-700
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	09/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding malposition involving triathlon baseplate was reported.The event was confirmed based on medical review.Method & results: device evaluation and results: not performed as product remained implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated.Conclusion of assessment: the patient underwent a right total knee arthroplasty.The surgeon reported that several of his cases of triathlon arthroplasties have resulted in the femoral component being in excessive valgus.I can confirm that this event took place since i was able to review the x-ray.Regarding the possible root cause of this event, with all due respect to the surgeon, this is iatrogenic and has nothing to do with the implant or instrumentation.I personally have performed over 3,000 primary and 80 revision procedures.The triathlon instrument system is extremely reliable.This is especially so when using intramedullary alignment guides on the femur.It is very predictable unless there is a extra articular deformity.If the surgeon is using extramedullary alignment, this error is common.I cannot tell for certain if this is a primary femoral component or a ts component.The ts component is designed to be positioned at 6° of valgus and the boss is fixed at 6°.Regarding the tibial component, there is an extra articular deformity of the tibia resulting in valgus alignment.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the event was confirmed based on medical review.The exact cause of the event could not be determined because insufficient information was provided.Additional information including return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Some of our important users believe triathlon implant has tendency to be at valgus alignment and some of their cases had this problem.The doctor asked his followers to cut distal femur at 3-4 valgus degrees for all triathlon cases.As he is among the top important kols for us and he is among core members of iran knee society, it is so vital for us to solve this problem.The cases is not robotic, it is manual tka.Update as per medical review: "the femoral component is positioned in excessive valgus in relation to the longitudinal axis of the femur.¿.
Additional Manufacturer Narrative
An event regarding malposition involving triathlon baseplate was reported.The event was confirmed based on medical review.Method & results: device evaluation and results: not performed as product remained implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated.Conclusion of assessment: the patient underwent a right total knee arthroplasty.The surgeon reported that several of his cases of triathlon arthroplasties have resulted in the femoral component being in excessive valgus.I can confirm that this event took place since i was able to review the x-ray.Regarding the possible root cause of this event, with all due respect to the surgeon, this is iatrogenic and has nothing to do with the implant or instrumentation.I personally have performed over 3,000 primary and 80 revision procedures.The triathlon instrument system is extremely reliable.This is especially so when using intramedullary alignment guides on the femur.It is very predictable unless there is a extra articular deformity.If the surgeon is using extramedullary alignment, this error is common.I cannot tell for certain if this is a primary femoral component or a ts component.The ts component is designed to be positioned at 6° of valgus and the boss is fixed at 6°.Regarding the tibial component, there is an extra articular deformity of the tibia resulting in valgus alignment.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the event was confirmed based on medical review.The exact cause of the event could not be determined because insufficient information was provided.Additional information including return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Some of our important users believe triathlon implant has tendency to be at valgus alignment and some of their cases had this problem.The doctor asked his followers to cut distal femur at 3-4 valgus degrees for all triathlon cases.As he is among the top important kols for us and he is among core members of iran knee society, it is so vital for us to solve this problem.The cases is not robotic, it is manual tka.Update as per medical review: "the femoral component is positioned in excessive valgus in relation to the longitudinal axis of the femur.¿.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #7
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13590551
• Report Number: 0002249697-2022-00273
• Device Sequence Number: 12249859
• Product Code: MBH
• UDI-Device Identifier: 07613327041064
• UDI-Public: 07613327041064
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2022

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 Model Number: 5520-B-700
• Device Catalogue Number: 5520B700
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown