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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5531G711
Device Problems Scratched Material (3020); Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Injury (2348)
Event Date 01/30/2018
Event Type  Injury  
Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other events for the lot referenced. There have been no other events for the sterile lot referenced. A supplemental report will be submitted upon completion of the investigation. The following devices were also listed in this report: triathlon cr fem comp #6 l-cem; 5510f601; b933s; triathlon prim cem fxd bplt #7; 5520b700; b3d7y; triathlon asymmetric x3 patella; 5551-g-401; np3w. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

 
Event Description

Patient had a primary total knee on (b)(6) 2017 and it became infected and surgeon removed the primary insert, washed out the joint, and put in a new insert.

 
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Brand NameX3 TRIATHLON CS INSERT #7 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
timothy rice
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7299585
MDR Text Key101056485
Report Number0002249697-2018-00559
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,Followup
Report Date 04/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/27/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5531G711
Device LOT NumberLFY721
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/15/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/04/2017
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: 02/27/2018 Patient Sequence Number: 1
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