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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5515-F-301
Device Problems Loss of Osseointegration (2408); Migration (4003)
Patient Problems Injury (2348); Osteolysis (2377); Inadequate Osseointegration (2646)
Event Date 06/07/2018
Event Type  Injury  
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 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.

 
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Brand NameTRIATHLON PS FEM COMPONENT, CEMENTED
Type of DevicePROSTHESIS, 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
brad curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9512805
MDR Text Key185009933
Report Number0002249697-2019-04090
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 12/23/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/23/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2020
Device Catalogue Number5515-F-301
Device LOT NumberNFRWA
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/30/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/23/2019 Patient Sequence Number: 1
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