EXTENDIBLE TOTAL HUMERAL REPLACEMENT - MINIMALLY INVASIVE GROWER UNK_STM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-03-25 for EXTENDIBLE TOTAL HUMERAL REPLACEMENT - MINIMALLY INVASIVE GROWER UNK_STM manufactured by Stanmore Implants Worldwide.

Event Text Entries

[188058851] The reported device is similar to a device approved for compassionate use in the united states. 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. Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. Device not returned.
Patient Sequence No: 1, Text Type: N, H10


[188058852] A patient specific prescription form was received reporting the following: left side. Reason for revision: luxation and instability. Device being requested is a total bayley walker shoulder. Proposed date of surgery is blank. Other notes are "bw type. Flexy elbow. Elbow stem 50mm. Overall replacement - 10mm shorter than current replacement (with extension). "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004105610-2020-00071
MDR Report Key9877371
Report SourceHEALTH PROFESSIONAL,OTHER
Date Received2020-03-25
Date of Report2020-03-25
Date of Event2020-02-26
Date Mfgr Received2020-02-26
Device Manufacturer Date2018-06-11
Date Added to Maude2020-03-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. COLLIN NEITZEL
Manufacturer Street325 CORPORATE DRIVE
Manufacturer CityMAHWAH NJ 07430
Manufacturer CountryUS
Manufacturer Postal07430
Manufacturer Phone2018315000
Manufacturer G1STANMORE IMPLANTS WORLDWIDE
Manufacturer Street210 CENTENNIAL AVENUE CENTENNIAL PARK, ELSTREE
Manufacturer CityBOREHAMWOOD WD6 3SJ
Manufacturer CountryGB
Manufacturer Postal CodeWD6 3SJ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEXTENDIBLE TOTAL HUMERAL REPLACEMENT - MINIMALLY INVASIVE GROWER
Generic NamePROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Product CodeKWS
Date Received2020-03-25
Catalog NumberUNK_STM
Lot NumberPIN 21343
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTANMORE IMPLANTS WORLDWIDE
Manufacturer Address210 CENTENNIAL AVENUE CENTENNIAL PARK, ELSTREE BOREHAMWOOD WD6 3SJ GB WD6 3SJ


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.