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

Model Number 5515-F-501

Device Problems Loss of Osseointegration (2408); Malposition of Device (2616)

Patient Problems Ambulation Difficulties (2544); Inadequate Osseointegration (2646)

Event Date 05/10/2022

Event Type  Injury  

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.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.

Event Description

Revision of ps femur to ts femur with augments.Femoral component had changed alignment since original surgery in (b)(6) 2021 and is now in 10deg valgus according to precision navigation.On x-ray the surgeon stated the alignment now look valgus.Tibial components not revised.Ts liner implanted.Left side.

Event Description

Revision of ps femur to ts femur with augments.Femoral component had changed alignment since original surgery in (b)(6) 2021 and is now in 10deg valgus according to precision navigation.On x-ray the surgeon stated the alignment now look valgus.Tibial components not revised.Ts liner implanted.Left side.

Manufacturer Narrative

Reported event: an event regarding loosening involving a triathlon femoral component 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 was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: this inquiry concerns a patient who had a primary cemented triathlon ps total knee arthroplasty with a stem extension on the tibia.Less than one year later the patient required revision for a "change in position" of the femoral component.The surgeon elected to use a non-stryker cement.I can only assume that the "change in position" of the femoral component was due to early loosening.There was nothing in the history to suggest trauma.In my experience, early loosening of a cemented femoral component is uncommon.It can occur if infection is present but aseptic loosening is unusual.I cannot confirm that a ¿change in position¿ occurred.I cannot determine the root cause of this event.Causes of early movement of a femoral component are multifactorial.If infection is present this could be a cause.In the absence of infection trauma can cause a change in position due to disruption of the cement mantle or fracture.Surgical technique can also be a factor especially regarding the technique of cementing.The use of a competitor cement brings into question the strength and other characteristics of the product.I have no knowledge of the track record or performance of this particular cement.The performance and clinical outcomes of cemented triathlon total knee arthroplasty is excellent and early femoral loosening is extremely uncommon.This may be due to surgical technique but i cannot be certain of this.I would rule out 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 have been no other similar events for the lot referenced.Conclusion: a review of the provided medical records by a clinical consultant indicated: this inquiry concerns a patient who had a primary cemented triathlon ps total knee arthroplasty with a stem extension on the tibia.Less than one year later the patient required revision for a "change in position" of the femoral component.The surgeon elected to use a non-stryker cement.I can only assume that the "change in position" of the femoral component was due to early loosening.There was nothing in the history to suggest trauma.In my experience, early loosening of a cemented femoral component is uncommon.It can occur if infection is present but aseptic loosening is unusual.I cannot confirm that a ¿change in position¿ occurred.I cannot determine the root cause of this event.Causes of early movement of a femoral component are multifactorial.If infection is present this could be a cause.In the absence of infection trauma can cause a change in position due to disruption of the cement mantle or fracture.Surgical technique can also be a factor especially regarding the technique of cementing.The use of a competitor cement brings into question the strength and other characteristics of the product.I have no knowledge of the track record or performance of this particular cement.The performance and clinical outcomes of cemented triathlon total knee arthroplasty is excellent and early femoral loosening is extremely uncommon.This may be due to surgical technique but i cannot be certain of this.I would rule out any causality to the implant itself.

• Brand Name: TRIATHLON PS FEM COMPONENT, CEMENTED
• Type of Device: 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14540110
• MDR Text Key: 292971622
• Report Number: 0002249697-2022-00782
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050394
• UDI-Public: 07613327050394
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K042993
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5515-F-501
• Device Catalogue Number: 5515-F-501
• Device Lot Number: EV77XD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 67 KG