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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-609
Device Problem Insufficient Information (3190)
Patient Problems Sepsis (2067); Injury (2348)
Event Date 10/11/2016
Event Type  Injury  
Manufacturer Narrative

The following devices were also listed in this report: triathlon ps fem comp #7l-cem; cat# 5515-f-701; lot# edm9j. Triathlon prim tib baseplate - cemented; cat# 5520-b-600; lot# iwzma. Triathlon symmetric x3 patella; cat# 5550-g-360; lot# 071e. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. It was noted that the device is not available for evaluation. Additional information has been requested. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation. Not returned to the manufacturer.

 
Event Description

Patient underwent 2 stage exchange following primary tka in 2013. Patient had septic sepsis and underwent a 2 stage exchange over the course of 4 months due to other health issues.

 
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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-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
sarah smelko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6417000
MDR Text Key70324780
Report Number0002249697-2017-00942
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 STUDY
Reporter Occupation
Type of Report Initial
Report Date 03/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/20/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5532-G-609
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 03/20/2017 Patient Sequence Number: 1
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