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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C Back to Search Results
Catalog Number 5515-F-502
Device Problem Off-Label Use (1494)
Patient Problem Injury (2348)
Event Date 07/03/2017
Event Type  Injury  
Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies. There have been no other events for the lot referenced. It was noted that the device is not available for evaluation. Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation. Not available.

 
Event Description

It was reported that a surgeon cemented and removed a right femoral component in patient's left knee. Revision and replacement required a 5mm distal, medial augment on the new ps femur. The revision was due to the fact that a right femoral component was cemented onto a left femur. It was removed and when removed some bone loss required a 5mm augment. There were no extraordinary circumstances present in the or during the procedure. It was a collective oversight by the entire staff, sales rep, and surgeon.

 
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Brand NameTRIATHLON PS FEM COMPONENT, CEMENTED
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
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
brian lauro
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6755327
MDR Text Key81464123
Report Number0002249697-2017-02337
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
Report Date 07/31/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/31/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5515-F-502
Device LOT NumberJSOHD
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 Received07/03/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/18/2016
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: 07/31/2017 Patient Sequence Number: 1
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