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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIATHLON #6/9 CR INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIATHLON #6/9 CR INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number UNK_JR
Device Problem Insufficient Information (3190)
Patient Problems Edema (1820); Pain (1994)
Event Date 09/13/2011
Event Type  Injury  
Manufacturer Narrative

The following devices were also listed in this report: triathlon #6 femur; cat# unknown; lot# unknown. Triathlon #6 tibia; cat# unknown; lot# unknown. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

 
Event Description

Medical review for a related report noted the following: on (b)(6) 2011 a primary right total knee arthroplasty was performed for which a brief handwritten operative note is available and indicates a triathlon #6 femur, #6 tibia, #6/9 cr insert, and palacos cement with gentamycin were utilized, and no patellar resurfacing was performed. Uncomplicated surgery was described. On (b)(6) 2011 "excellent result from right total knee" is noted. When seen on (b)(6) 2011 it was noted, "0° to 110°. Complains of anterior right knee pain. " on a (b)(6) 2011 visit it was noted, "hips continue to work perfectly. Complains of right knee swelling and pain. ".

 
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Brand NameUNKNOWN TRIATHLON #6/9 CR 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 Key8907381
MDR Text Key156713716
Report Number0002249697-2019-02899
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 08/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/19/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_JR
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/19/2019 Patient Sequence Number: 1
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