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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-511
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Fever (1858); Unspecified Infection (1930); Chills (2191); Injury (2348); Sweating (2444)
Event Date 08/12/2016
Event Type  Injury  
Manufacturer Narrative
The following devices were also listed in this report: triathlon ps fem component, cemented; cat# 5515-f-501; lot# jgpsa; tri ts baseplate size 5; cat# 5521-b-500; lot# jbnh; triathlon symmetric x3 patella; cat# 5550-g-360; lot# w2pa; tri cemented stem 12mmx50mm; cat# 5560-s-112; lot# m8n2j.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device 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.Not returned to the manufacturer.
 
Event Description
Patient was almost three years out from primary bilateral tka.Patient woke up in the middle of the night with chills, sweating, and elevated temperature.Was immediately worked up for infection, with ultimate diagnosis as acute hematogenous pji.An irrigation and debridement was performed with a poly liner exchange.Left hip revision.
 
Manufacturer Narrative
An event regarding infection involving a triathlon insert was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-medical records received and evaluation: no medical records or x-rays were made available for evaluation.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the reported lot and sterile lot.Conclusions: the source of the infection could not be determined as patient information, clinical history, and results of blood work for infection were not provided.A capa trend analysis was conducted for the reported failure mode and concluded infection is most likely a result from other factors not necessarily related to the device in the healthcare facility setting.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 was almost three years out from primary bilateral tka.Patient woke up in the middle of the night with chills, sweating, and elevated temperature.Was immediately worked up for infection, with ultimate diagnosis as acute hematogenous pji.An irrigation and debridement was performed with a poly liner exchange.Left hip revision.
 
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Brand Name
TRIATHLON PS X3 TIBIAL INSERT
Type of Device
PROSTHESIS, 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 Key6227223
MDR Text Key64015810
Report Number0002249697-2017-00104
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2017
Device Catalogue Number5532-G-511
Device Lot NumberMLP45H
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/23/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age58 YR
Patient Weight93
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