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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE FEMORAL STEM CURVED LIMB SALVAGE SYSTEM

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STANMORE IMPLANTS WORLDWIDE FEMORAL STEM CURVED LIMB SALVAGE SYSTEM Back to Search Results
Catalog Number UNK_STM
Device Problems Incorrect Device Or Component Shipped (2962); Packaging Problem (3007)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 09/25/2015
Event Type  malfunction  
Manufacturer Narrative
The cause of the event has been determined as a missing process step. The following corrective actions have been implemented - device history record release approval work instruction has been updated to include a step to check all routing operations are correct. - the device history record has been updated to include a manufacturing step that gives indication for a curved stem. - the inspection check sheet has been updated to include a check for the missed operation. No further investigation for this event is possible at this time as the device was not returned and insufficient information was received by siw. If devices and / or additional information become available, this investigation will be reopened.
 
Event Description
It has been reported that a curved stem box was picked but a straight stem was inside.
 
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. Device not available.
 
Event Description
It has been reported that a curved stem box was picked but a straight stem was inside.
 
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Brand NameFEMORAL STEM CURVED
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 Key6402199
MDR Text Key195041325
Report Number3004105610-2017-00018
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K121029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 07/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_STM
Device Lot NumberB10211
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 Received07/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/14/2017 Patient Sequence Number: 1
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