PROSTHETIC RADIAL HEAD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-12-20 for PROSTHETIC RADIAL HEAD manufactured by Wright Medical Technologies.

Event Text Entries

[200500] "a radial head replacement arthroplasty using wright modular radial head prosthesis, 9. 5 mmstem, 28 mm/0 head component". This component was used after the pt had suffered a fracture dislocation of their left elbow. The surgical procedure was to excise the radial head and place a prosthetic radial head in position to recontruct that element and provide better stabilization of the elbow.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number310681
MDR Report Key310681
Date Received2000-12-20
Date of Report2000-12-12
Date of Event2000-11-14
Date Facility Aware2000-12-08
Report Date2000-12-12
Date Reported to Mfgr2000-12-12
Date Added to Maude2001-01-05
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameNI
Generic NamePROSTHETIC RADIAL HEAD
Product CodeKIG
Date Received2000-12-20
Model NumberNI
Catalog NumberNI
Lot Number099A108123
ID NumberREF: 496-H028
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age20 DAY
Implant FlagY
Date RemovedV
Device Sequence No1
Device Event Key300546
ManufacturerWRIGHT MEDICAL TECHNOLOGIES
Manufacturer AddressP.O. BOX 100 ARLINGTON TN 38002 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2000-12-20

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