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

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE TIBIAL COMPONENT FIXED HINGE LIMB SALVAGE SYSTEM

  • 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
 

STANMORE IMPLANTS WORLDWIDE TIBIAL COMPONENT FIXED HINGE LIMB SALVAGE SYSTEM Back to Search Results
Model Number MKFH/STDLG
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 09/07/2017
Event Type  malfunction  
Manufacturer Narrative
While the device was incorrectly labelled on the outside the was no risk to patient as the device was correctly labelled on the inside and the error was identified prior to surgery. On completion of the investigation into the reported event it can be concluded that the incident does not meet the three basic reporting criteria referenced in 21 cfr part 803 as a marketed device did not cause or contribute to a death or serious injury, or a marketed device has not malfunctioned where the malfunction of the device or a similar marketed device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Product surveillance will continue to monitor for trends.
 
Event Description
It has been reported that when the customer received a tibial fixed hinge assembly, the label was green in colour when it should have been red. The issue was noticed during a stock check, there were no patient adverse consequences for this event.
 
Manufacturer Narrative
An investigation is being performed in an attempt to identify the cause of the event. Should additional information become available, it will be reported in a supplemental report upon completion of the investigation.
 
Event Description
It has been reported that when the customer received a tibial fixed hinge assembly, the label was green in colour when it should have been red. The issue was noticed during a stock check, there were no patient adverse consequences for this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTIBIAL COMPONENT FIXED HINGE
Type of DeviceLIMB SALVAGE SYSTEM
Manufacturer (Section D)
STANMORE IMPLANTS WORLDWIDE
210 centennial avenue
centennial park, elstree
borehamwood WD6 3 SJ
GB WD6 3SJ
Manufacturer (Section G)
STANMORE IMPLANTS WORLDWIDE
210 centennial avenue
centennial park, elstree
borehamwood WD6 3 SJ
GB WD6 3SJ
Manufacturer Contact
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood WD6 3-SJ
GB   WD6 3SJ
2082386500
MDR Report Key6864787
MDR Text Key246032431
Report Number3004105610-2017-00065
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K121029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/28/2020
Device Model NumberMKFH/STDLG
Device Catalogue NumberUNK_STM
Device Lot NumberA12273/Z6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/12/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-