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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #4 R-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #4 R-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5510F402
Device Problem Mechanical Problem (1384)
Patient Problem No Information (3190)
Event Date 09/01/2015
Event Type  Injury  
Manufacturer Narrative

Review of the device history records indicates that devices were manufactured and accepted into final stock with no reported discrepancies. Review of complaint database reveled that there have been no other events for the lot referenced. This event was reported via clinical outcomes reporting studies. An evaluation of the device cannot be performed as the device was not made available 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

Postopertive diagnosis: patient underwent a revision for mechanical problems. Femoral and tibial component, and liner revised. Patella component retained.

 
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Brand NameTRIATHLON CR FEM COMP #4 R-CEM
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
jadwiga degrado
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5316256
MDR Text Key34046924
Report Number0002249697-2015-04446
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 12/08/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2019
Device Catalogue Number5510F402
Device LOT NumberEL87B
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 Received12/08/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/09/2014
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: 12/21/2015 Patient Sequence Number: 1
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