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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-511
Device Problems Material Discolored (1170); Scratched Material (3020); Insufficient Information (3190)
Patient Problems Edema (1820); Unspecified Infection (1930); Injury (2348)
Event Date 02/23/2018
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Poly ethylene exchange for recurrent effusions. As reported in ¿how was issue noticed¿, ¿patient getting effusions, infection and loosening negative. ".

 
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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
timothy rice
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7365314
MDR Text Key103294091
Report Number0002249697-2018-00860
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 05/22/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/23/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2018
Device Catalogue Number5532-G-511
Device LOT NumberMMNEP1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/12/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/19/2013
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: 03/23/2018 Patient Sequence Number: 1
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