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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-302
Device Problem Osseointegration Problem (3003)
Patient Problems Injury (2348); Inadequate Osseointegration (2646)
Event Date 12/03/2014
Event Type  Injury  
Manufacturer Narrative

An event regarding loosening involving a triathlon femoral component was reported. The event was confirmed through clinician review of provided medical records. Method & results : product evaluation and results: not performed as no product was returned for evaluation. Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: there is some information available in the medical records to suggest that component malposition has played a relevant role in the failure mode of this triathlon ps arthroplasty due to fixation failure. Lack of x-ray availability at this time prevents to establish this with more certainty. Product history review: indicated all devices accepted into final stock were free from discrepancies. Complaint history review: there have been no other similar events for the lot referenced. Conclusions: a review of the provided medical records and x-rays by a clinical consultant indicated: there is some information available in the medical records to suggest that component malposition has played a relevant role in the failure mode of this triathlon ps arthroplasty due to fixation failure. Lack of x-ray availability at this time prevents to establish this with more certainty. 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

This pi is for right knee. It was reported through the communication of an attorney that allegedly the patient was revised due to a failed right total knee arthroplasty. Update (b)(6) 2019: medical review stated the following: right knee revision surgery was performed on (b)(6) 2018. During revision, both tibial baseplate and femoral component appeared loose and could be removed without undue bone damage. The patellar component was intact without issues and was as such retained. Conclusion of assessment: there is some information available in the medical records to suggest that component malposition has played a relevant role in the failure mode of this triathlon ps arthroplasty due to fixation failure. Lack of x-ray availability at this time prevents to establish this with more certainty.

 
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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
collin neitzel
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9355096
MDR Text Key168178911
Report Number0002249697-2019-03843
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 11/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/21/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2017
Device Catalogue Number5515-F-302
Device LOT NumberGXMJD
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/17/2012
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: 11/21/2019 Patient Sequence Number: 1
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