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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-413
Device Problem Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Injury (2348)
Event Date 11/25/2015
Event Type  Injury  
Manufacturer Narrative
The following other devices were also listed in this report: tri cemented stem 12mmx50mm; cat# 5560-s-112; lot# 0036905i.Tri lm/rl tib aug sz4 5mm; cat# 5545-a-401; lot# fuhha.Tri rm/ll tib aug sz4 5mm; cat# 5545-a-402; lot# er9km7e.Triathlon symmetric x3 patella; cat# 5550-g-319; lot# kp9t.Tri ts baseplate size 4; cat# 5521-b-400; lot# tbv3a.Triathlon ps fem component, cemented; cat# 5515-f-401; lot# mrrrsw3a.It cannot be determined which, if any of these devices may have caused or contributed to the patient's infection.An evaluation of the device cannot be performed as the device was retained by the hospital 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
Due to infection dr swapped poly and irrigated left knee.
 
Manufacturer Narrative
An event regarding infection involving a triathlon insert was reported.The event was not confirmed.Method and results: device evaluation and results: could not be performed as no items associated with the event were returned or made available for evaluation.Medical records received and evaluation: insufficient medical records were received for review with a clinical consultant.Device history review: indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced and the 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 insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.
 
Event Description
Due to infection doctor swapped poly and irrigated left knee.
 
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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
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5312262
MDR Text Key33923691
Report Number0002249697-2015-04313
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 Physician
Type of Report Initial,Followup
Report Date 11/25/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/31/2019
Device Catalogue Number5532-G-413
Device Lot NumberMNJLTD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/25/2015
Initial Date FDA Received12/18/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/03/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/16/2014
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 Age49 YR
Patient Weight121
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