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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON SYMMETRIC X3 PATELLA PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5550-G-278
Device Problem Crack (1135)
Patient Problem Injury (2348)
Event Date 06/21/2019
Event Type  Injury  
Manufacturer Narrative

Further investigation of the returned device is ongoing at this time. When a full investigation has been carried out a supplemental report will be made available.

 
Event Description

It was reported that the patient's right knee was revised due to a cracked cr insert. Patient was revised to a 13mm cs insert.

 
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Brand NameTRIATHLON SYMMETRIC X3 PATELLA
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
margaret foley
raheen business park
limerick NA
61498200
MDR Report Key8960487
MDR Text Key157096182
Report Number0002249697-2019-03080
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 10/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/04/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2015
Device Catalogue Number5550-G-278
Device LOT NumberB724
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/08/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/15/2010
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: 09/04/2019 Patient Sequence Number: 1
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