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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5532-G-311
Device Problem Insufficient Information (3190)
Patient Problems Injury (2348); Fluid Discharge (2686)
Event Date 05/24/2016
Event Type  Injury  
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was sent to pathology and was not returned to the manufacturer. Additional information has been requested. Should additional information become available it will be reported in a supplemental report upon completion of the investigation. Not returned to the manufacturer.

 
Event Description

Dr. (b)(6). Reports patient (b)(6). Status post right knee revision(poly exchange) done on (b)(6) 2016 has a small draining sinus tract. Dr. (b)(6). Decided he wanted to wash out and debride the surgical site and change the poly again. After washing out the surgical site he exchanged the poly to a 13mm thick ps insert. The surgical site was closed. The surgery was performed without incidence.

 
Manufacturer Narrative

Reported event: an event regarding revision involving a triathlon insert was reported. The event was not confirmed. Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned. -medical records received and evaluation: no medical records or x-rays were made available for evaluation. -device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced. Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided. If the devices and/or additional information are received, this investigation will be reopened and re-evaluated. Product surveillance will continue to monitor for trends.

 
Event Description

Dr. (b)(6) reports patient (b)(6) status post right knee revision(poly exchange) done on (b)(6) 2016 has a small draining sinus tract. Dr. (b)(6) decided he wanted to wash out and debride the surgical site and change the poly again. After washing out the surgical site he exchanged the poly to a 13mm thick ps insert. The surgical site was closed. The surgery was performed without incidence.

 
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Brand NameTRIATHLON PS X3 TIBIAL INSERT
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
jadwiga degrado
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5739579
MDR Text Key47891089
Report Number0002249697-2016-01995
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 HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/24/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/21/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device EXPIRATION Date03/31/2020
Device Catalogue Number5532-G-311
Device LOT Number2M51KV
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/20/2015
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: 06/21/2016 Patient Sequence Number: 1
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