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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #3 L-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #3 L-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5510F301
Device Problem Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/23/2018
Event Type  Malfunction  
Manufacturer Narrative

Review of the device history records indicate were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other similar events for the reported lot. It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

 
Event Description

Incorrect size 3 cr left femur implanted onto a right sided femur. Implant checked by myself, nurse and surgeon prior to opening. Knee tracked well after implantation and not noticed until todays x-ray meeting. Update 06 nov 2018; was the incorrect sized device selected in error or did the device size differ to the packaging? the incorrect sided device was chosen in error.

 
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Brand NameTRIATHLON CR FEM COMP #3 L-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
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8108781
MDR Text Key129328493
Report Number0002249697-2018-03840
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeAU
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 11/27/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/27/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5510F301
Device LOT NumberBNN4L
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 Received10/30/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/26/2016
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: 11/27/2018 Patient Sequence Number: 1
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