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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-613
Device Problems Malposition of Device (2616); No Apparent Adverse Event (3189)
Patient Problems Fall (1848); Pain (1994); Injury (2348)
Event Date 11/10/2016
Event Type  Injury  
Manufacturer Narrative

It was noted that the device is not available for evaluation the following devices were also listed in this report: triathlon symmetric x3 patella; cat# 5550-g-339; lot# nwk6 triathlon fix. Peg 2 per pk; cat# 5575-x-000; lot# ekj7r triathlon ps fem component, cemented; cat# 5515-f-601; lot# jwxua triathlon prim tib baseplate - cemented; cat# 5520-b-600; lot# kjlea unknown device; cat# reported as 00-1112-140-01; lot# 77604366 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation. Not returned to the manufacturer.

 
Event Description

His knee keeps giving out due to pain. Knee keeps popping out of place. He has fallen 20 times. A scheduled revision on monday (b)(6) 2016 due to pain.

 
Manufacturer Narrative

An event regarding loosening involving a triathlon insert was reported. Conclusion: there is no indication that the product reported in this investigation contributed to the event since patient was revised due to aseptic loosening of femoral and tibial components. No other allegations were made against the insert therefore it is considered as concomitant. No further investigation is required at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

His knee keeps giving out due to pain. Knee keeps popping out of place. He has fallen 20 times. A scheduled revision on monday (b)(6) 2016 due to pain.

 
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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
cindy chuhinko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6154617
MDR Text Key61732192
Report Number0002249697-2016-03859
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 03/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/08/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2019
Device Catalogue Number5532-G-613
Device LOT NumberMNMPR1
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 Received02/21/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/05/2014
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: 12/08/2016 Patient Sequence Number: 1
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