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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5530-G-213
Device Problems Material Deformation (2976); Scratched Material (3020); Insufficient Information (3190)
Patient Problems Pain (1994); Swelling (2091); Injury (2348)
Event Date 04/28/2010
Event Type  Injury  
Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock on with no relevant reported discrepancies. There have been no other events for the reported lot. A supplemental report will be submitted upon completion of the investigation. The following devices were also listed in this report: triathlon cr fem comp #3 l-cem; cat#5510f301; lot# srrty, triathlon asymmetric x3 patella; cat35551-g-299; lot# 00e5, triathlon prim cem fxd bplt #2; cat#5520b200; lot# snbsp. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

 
Event Description

Patient called and stated that she had a left tka on (b)(6) 2010. Patient stated that she experienced pain, swelling and stiffness since day one and never got better. Patient stated that she had a revision done on or about (b)(6) 2011.

 
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Brand NameTRIATHLON CR X3 TIBIAL INSERT
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 Key7309203
MDR Text Key101361204
Report Number0002249697-2018-00601
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 OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/02/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2013
Device Catalogue Number5530-G-213
Device LOT NumberLBD650
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/16/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/16/2008
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: 03/02/2018 Patient Sequence Number: 1
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