• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 11MM KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 11MM KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS Back to Search Results
Catalog Number 5531G411
Device Problem Insufficient Information (3190)
Patient Problems Sepsis (2067); Injury (2348)
Event Date 09/20/2015
Event Type  Injury  
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy. Additional information has been requested but not provided due to hospital policy. 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

It was reported that surgeon revised patient's right knee insert to rule out early knee sepsis.

 
Manufacturer Narrative

An event regarding infection involving a triathlon insert was reported. The event was not confirmed. Method & results: -device evaluation and results: visual, dimensional and functional inspections were not performed as the product was not returned. -medical records received and evaluation: not performed as medical records were not provided. -device history review: not performed as the lot code provided is invalid. -complaint history review: not performed as the lot code provided is invalid. Conclusions: the exact root cause of the event could not be determined due to insufficient provision of information. Further information such as: product details, return of reported devices; pre- and post-operative x-rays; operative reports as well as patient history, follow up notes and pathology reports are needed to complete the investigation to determine root cause. A capa trend analysis was conducted for the reported failure mode and concluded infection is a known possible adverse outcome of surgery and is beyond stryker's control. 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

It was reported that surgeon revised patient's right knee insert to rule out early knee sepsis.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameX3 TRIATHLON CS INS SIZE4 11MM
Type of DeviceKNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-LIMERICK
raheen business park
limerick 00000
Manufacturer Contact
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5147338
MDR Text Key28138513
Report Number0002249697-2015-03378
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
Type of Report Initial,Followup
Report Date 09/20/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/14/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2019
Device Catalogue Number5531G411
Device LOT NumberLDS620
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 Received11/04/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/31/2014
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: 10/14/2015 Patient Sequence Number: 1
-
-