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-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.

• 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: collin neitzel ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9355096
• MDR Text Key: 168178911
• Report Number: 0002249697-2019-03843
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050363
• UDI-Public: 07613327050363
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• 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 Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 5515-F-302
• Device Lot Number: GXMJD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2012
• 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: 53 YR