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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE PROXIMAL TIBIA MINIMALLY INVASIVE GROWER (MIG) PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STANMORE IMPLANTS WORLDWIDE PROXIMAL TIBIA MINIMALLY INVASIVE GROWER (MIG) PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number UNK_STM
Device Problems Osseointegration Problem (3003); Insufficient Information (3190)
Patient Problems Bone Fracture(s) (1870); Injury (2348); Inadequate Osseointegration (2646); Cancer (3262)
Event Date 03/17/2020
Event Type  Injury  
Manufacturer Narrative
The reported device is similar to a device approved for compassionate use in the united states. Review of the product history records indicate device was manufactured and accepted into final stock with no reported discrepancies. 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. Not returned to the manufacturer.
 
Event Description
A patient specific prescription form was received for the patient's proximal tibia with the following notes, "femoral shaft with stress shielding, distal femur/long stem. ".
 
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Brand NamePROXIMAL TIBIA MINIMALLY INVASIVE GROWER (MIG)
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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, NJ WD6 3-SJ
GB   WD6 3SJ
2018315000
MDR Report Key9962933
MDR Text Key188058179
Report Number3004105610-2020-00084
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGB
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 05/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 16729
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 Received05/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/24/2011
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: 04/15/2020 Patient Sequence Number: 1
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