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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-619
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Cellulitis (1768); Unspecified Infection (1930); Sepsis (2067); Injury (2348)
Event Date 07/22/2017
Event Type  Injury  
Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

 
Event Description

It was reported that the surgeon performed a bilateral revision on a patient's right knee, due to the presence of sepsis and cellulitis. Rep reports "incision drainage where triathlon poly were replaced".

 
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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
brian lauro
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6802408
MDR Text Key82979326
Report Number0002249697-2017-02520
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 11/15/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/17/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/22/2012
Device Catalogue Number5532-G-619
Device LOT NumberEE5MKD
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/28/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/22/2007
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: 08/17/2017 Patient Sequence Number: 1
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