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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #6 13MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #6 13MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5531G613
Device Problems Material Deformation (2976); Insufficient Information (3190)
Patient Problems Arthritis (1723); Rheumatoid Arthritis (1724); Pain (1994); Injury (2348)
Event Date 11/15/2017
Event Type  Injury  
Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

 
Event Description

The patient underwent initial tka surgery on (b)(6) 2016. The patient's underlying disease was rheumatoid arthritis. One year after the primary surgery, the patient complained of pain of the treated knee, and the revision surgery, which was exchanged only the cs insert, was performed on (b)(6) 2017.

 
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Brand NameX3 TRIATHLON CS INSERT #6 13MM
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
timothy rice
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7102616
MDR Text Key94344064
Report Number0002249697-2017-03528
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
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 02/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/10/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/25/2019
Device Catalogue Number5531G613
Device LOT NumberLDY511
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/07/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/25/2014
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: 12/10/2017 Patient Sequence Number: 1
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