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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5532-G-609
Device Problem Insufficient Information (3190)
Patient Problems Swelling (2091); Joint Swelling (2356); Fluid Discharge (2686)
Event Date 01/22/2013
Event Type  Injury  
Manufacturer Narrative

An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer. Additional information has been requested. Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

 
Event Description

Patient has been experiencing swelling and clicking. Knee was drained approximately 3 months after surgery.

 
Manufacturer Narrative

The following other devices were added to this report after submission of the initial report: triathlon ps fem component, cemented; cat# 5515-f-602; lot# gzmra, triathlon prim tib baseplate - cemented; cat# 5520-b-600; lot# hlxya, triathlon asymmetric x3 patella; cat# 5551-g-350; lot# 45wt, simplex p with tobramycin 1 pack; cat# 6197-9-001; lot# mit083. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. An event regarding audible noise involving a triathlon insert was reported. The event was confirmed. Method & results: device evaluation and results: the device remains implanted. Medical records received and evaluation: the provided medical records were reviewed by a consulting clinician who indicated: this appears to be nonspecific and without evident cause. There is no evidence of implant failure. Device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there has been no other event for the lot referenced. Conclusions: the exact cause of the event regarding audible noise could not be determined from the information provided. A review of the provided records by a clinical consultant concluded that the medical records "this appears to be nonspecific and without evident cause. There is no evidence of implant failure. " no further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics. If devices and/or additional information become available, this investigation will be reopened.

 
Event Description

Patient has been experiencing swelling and clicking. Knee was drained approximately 3 months after surgery.

 
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Brand NameTRIATHLON PS 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
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5271158
MDR Text Key32806298
Report Number0002249697-2015-04145
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,Followup
Report Date 11/11/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/07/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2017
Device Catalogue Number5532-G-609
Device LOT NumberMLKA3A
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 Received03/28/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/11/2012
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: 12/07/2015 Patient Sequence Number: 1
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