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

Catalog Number	5515-F-301
Medical Device Problem Codes	Loss of Osseointegration (2408); Migration (4003)
Health Effect - Clinical Codes	Injury (2348); Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	06/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding loosening, instability, subsidence and bone resorption 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.Medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: multiple procedure-related factors including poor femoral cementation technique with malalignment of the knee in excessive valgus further contributing to an overload condition and the pain magnified by patellofemoral overstuffing have in concert contributed to immediate fixation failure of the triathlon ps/ts femoral component within the first few weeks post primary surgery on (b)(6) 2016, causing severe and persistent pain with functional limitations and secondary instability ultimately requiring revision surgery with exchange of all triathlon devices to depuy revision knee devices on (b)(6) 2018.Procedural related factors including poor cementation technique of the femoral device, secondary mid mlexion instability of the knee, tibio-femoral malalignment in excessive valgus of 10° and excessive thickness of remaining patellar bone contributed to the event.Patient factor, osteoporosis of knee bone as minor factor, also contributed to the event.No device-related factors are associated with any of the implanted devices at any time.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: multiple procedure-related factors including poor femoral cementation technique with malalignment of the knee in excessive valgus further contributing to an overload condition and the pain magnified by patellofemoral overstuffing have in concert contributed to immediate fixation failure of the triathlon ps/ts femoral component within the first few weeks post primary surgery on (b)(6) 2016, causing severe and persistent pain with functional limitations and secondary instability ultimately requiring revision surgery with exchange of all triathlon devices to depuy revision knee devices on (b)(6) 2018.Procedural related factors including poor cementation technique of the femoral device, secondary mid flexion instability of the knee, tibio-femoral malalignment in excessive valgus of 10° and excessive thickness of remaining patellar bone contributed to the event.Patient factor, osteoporosis of knee bone as minor factor, also contributed to the event.No device-related factors are associated with any of the implanted devices at any time.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.Not returned.
Event or Problem Description
It was reported through the communication of an attorney that allegedly the patient was revised due to failed left total knee arthroplasty.Update on 26-nov-2019 by qs based on medical review: left knee revision surgery was performed on (b)(6) 2018, under the diagnosis of ¿failed left knee arthroplasty¿ with exchange of all stryker components for non stryker revision knee devices.At exploration, the instability was confirmed and the patella was found too thick with 28-mm.The femoral component was deemed loose as it could be ¿popped out¿ without effort.Only 7-weeks post surgery, the second x-rays of (b)(6) 2016, confirmed already significant proximal migration of the femoral component with more than 1-cm subsidence compared with the previous x-ray of (b)(6) 2016, with lucency and bone resorption along almost the entire femoral implant-bone interface.

• Brand Name: TRIATHLON PS FEM COMPONENT, CEMENTED
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9512805
• Report Number: 0002249697-2019-04090
• Device Sequence Number: 11455436
• Product Code: MBH
• UDI-Device Identifier: 07613327050356
• UDI-Public: 07613327050356
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/23/2019

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: 05/31/2020
• Device Catalogue Number: 5515-F-301
• Device Lot Number: NFRWA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 54 YR