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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 16MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 16MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5531G416
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Swelling (2091); Burning Sensation (2146)
Event Date 07/28/2016
Event Type  Injury  
Manufacturer Narrative

It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation. The following devices were also listed in this report: unknown triathlon #4 femoral tibial component ; cat#unknown; lot#unknown. Unknown 32 mm patella component; cat#unknown; lot#unknown. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

 
Event Description

It was reported by the patient that she started experiencing pain, swelling and burning sensation from her knee to her toe after her left tka. Patient stated her neurologist diagnosed her with reflex sympathetic dystrophy (rsd).

 
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Brand NameX3 TRIATHLON CS INS SIZE4 16MM
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 NJ NA
Manufacturer Contact
juana hiciano
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7374577
MDR Text Key103593841
Report Number0002249697-2018-00905
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 08/14/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/27/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5531G416
Device LOT NumberLES234
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2018
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: 03/27/2018 Patient Sequence Number: 1
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