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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 9MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 9MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5537-G-509
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 07/07/2015
Event Type  Injury  
Manufacturer Narrative

The following other devices were also listed in this report: triathlon ps fem component, cemented; cat# 5515-f-602; lot# ehnyt. Tri ts baseplate size 5; cat# 5521-b-500; lot# hoit. Triathlon asym patella a35x10; cat# 5551l350; lot# lds064. It cannot be determined which, if any of these devices may have caused or contributed to the patient's infection. This event was reported via clinical outcomes reporting studies. An evaluation of the device cannot be performed as the device was not made available 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 underwent a liner exchange with i&d wash-out.

 
Manufacturer Narrative

An event regarding an unspecified involving a triathlon insert was reported. The event was not confirmed. Method & results: device evaluation: not performed as the subject device was not returned. Medical records received and evaluation: not performed as no medical records were provided for review. Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification. Complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot. Conclusions: the exact cause of the event could not be determined based on the information provided. Further information such as the reason why the revision surgery took place, product return, pre- and post-operative x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause. No further investigation is possible at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

Patient underwent a liner exchange with i&d wash-out.

 
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Brand NameNO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 9MM
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 navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5316265
MDR Text Key34047871
Report Number0002249697-2015-04449
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/08/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2018
Device Catalogue Number5537-G-509
Device LOT NumberMMK80X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/12/2013
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: 12/21/2015 Patient Sequence Number: 1
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