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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5531G311
Device Problems Delamination (2904); Material Distortion (2977); Naturally Worn (2988); Scratched Material (3020); Noise, Audible (3273)
Patient Problem Injury (2348)
Event Date 05/12/2017
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 similar events for the lot referenced. If additional information becomes available, a supplemental report will be submitted upon completion of the investigation.

 
Event Description

Polyethylene insert and femoral component revised. Surgeon reported loosening and squeaking.

 
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Brand NameX3 TRIATHLON CS INSERT #3 11MM
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
brian lauro
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6632449
MDR Text Key77273058
Report Number0002249697-2017-01813
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,Followup
Report Date 09/14/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/09/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/02/2014
Device Catalogue Number5531G311
Device LOT NumberLBK233
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/31/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/02/2009
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: 06/09/2017 Patient Sequence Number: 1
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