• 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 #1 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

  • 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 #1 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5531G111
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/26/2019
Event Type  Malfunction  
Manufacturer Narrative

A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies. There have been no other events for the lot referenced. If additional information is received, it will be provided in a supplemental report upon completion of the investigation. Device not available.

 
Event Description

It was reported by the sale rep that small gap was found in between tibia tray and tibia insert after the insert was log in to the tibia tray new tibia insert was used to completed the case.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameX3 TRIATHLON CS INS #1 11MM
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-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
collin neitzel
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8920707
MDR Text Key155199230
Report Number0002249697-2019-02935
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeMY
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/31/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/22/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue Number5531G111
Device LOT NumberLFK898
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/13/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/2016
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: 08/22/2019 Patient Sequence Number: 1
-
-