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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR LIMB SALVAGE SYSTEM

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STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR LIMB SALVAGE SYSTEM Back to Search Results
Catalog Number UNK_STM
Device Problem Insufficient Information (3190)
Patient Problems Inflammation (1932); Injury (2348)
Event Date 03/11/2019
Event Type  Injury  
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. Device not available.
 
Event Description
A patient specific implant prescription form was received for patient's impending revision with diagnosis "re-bushings dfr from 1989" additional notes indicate: re-bushings in 2012, bushes ref: stbsh01-02, bme: 17262, circlip: ref smcic01.
 
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Brand NameDISTAL FEMUR
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 Key8490785
MDR Text Key141165379
Report Number3004105610-2019-00043
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K140898
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 06/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/1995
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 3541
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 Received06/20/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/09/1995
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: 04/08/2019 Patient Sequence Number: 1
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