MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON SYMMETRIC X3 PATELLA; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 5550-G-360

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Pain (1994)

Event Date 07/16/2020

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding instability and crack/fracture involving an unknown patella 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.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: not performed as the device lot details were not provided.Complaint history review: not performed as the device lot details were not provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as product details, return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

The patient is a pleasant (b)(6)-year-old.Earlier this year, he had a ground level fall and has had persistent pain since that time.At that time, radiographs revealed no obvious problems with his implants.However, his symptoms persisted.We decided to proceed with surgical exploration with proposed synovectomy and evaluation of the extensor.He was returned to the operating room on (b)(6) 2020 for evaluation of the knee.At surgery, his patellar component was found to be in position, but unstable with shearing of the fixation pegs.He underwent revision of his patellar component.

Event Description

The patient is a pleasant 75-year-old.Earlier this year, he had a ground level fall and has had persistent pain since that time.At that time, radiographs revealed no obvious problems with his implants.However, his symptoms persisted.We decided to proceed with surgical exploration with proposed synovectomy and evaluation of the extensor.He was returned to the operating room on (b)(6) 2020 for evaluation of the knee.At surgery, his patellar component was found to be in position, but unstable with shearing of the fixation pegs.He underwent revision of his patellar component.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving a triathlon patella was reported.The event was confirmed through clinician review of the provided medical records.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: adverse event identified: patella implant fracture (shear of the pegs) requiring revision surgery and subsequent postoperative surgical site infection requiring revision surgery.Hazards: there was a potential hazard.The patellar component, by report, fractured-sheared off at the peg level and was loose.This required revision surgery and led to an infection.Conclusion of assessment: there was a patella implant fracture (shear of the pegs) that required revision surgery.A postoperative surgical site infection occurred and required another revision surgery.While there was some evidence of trauma, this would be an unusual failure mechanism especially with a cemented patella.Evaluation of the explant, assessment of radiographs, and operative notes from the patellar revision as well as an extended patient history may provide an ability to assess the root cause of the event.-device history review: all 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 reported lot.Conclusions: clinician review of the medical records provided indicated: there was a patella implant fracture (shear of the pegs) that required revision surgery.A postoperative surgical site infection occurred and required another revision surgery.While there was some evidence of trauma, this would be an unusual failure mechanism especially with a cemented patella.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, assessment of radiographs, operative reports from the patellar revision as well as an extended patient history are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON SYMMETRIC X3 PATELLA
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11541513
• MDR Text Key: 241426847
• Report Number: 0002249697-2021-00498
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 5550-G-360
• Device Lot Number: 3EYP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 100