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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-513
Device Problem Insufficient Information (3190)
Patient Problems Rheumatoid Arthritis (1724); Injury (2348)
Event Date 10/27/2011
Event Type  Injury  
Manufacturer Narrative

The following devices were also listed in this report: triathlon asymmetric x3 patella, cat#5551-g-350, lot#799z; triathlon cr fem comp #6 r-cem, cat#5510f602, lot#sjnmn; triathlon prim cem fxd bplt #5, cat#5520b500, lot#sj4xh. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. The information in this report was provided by stryker orthopaedics legal affairs department. No additional information is available at this time due to the ongoing litigation. Should additional information become available, the evaluation summary will be submitted in a supplemental report.

 
Event Description

It was reported through the communication of an attorney that allegedly the patient was revised due to acute failure status post right total knee arthroplasty; rheumatoid arthritis.

 
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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-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8964786
MDR Text Key156592376
Report Number0002249697-2019-03090
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 CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 09/05/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/05/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2013
Device Catalogue Number5530-G-513
Device LOT Number6PKMME
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/27/2008
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: 09/05/2019 Patient Sequence Number: 1
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