UNKNOWN ULNA STEM NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2020-03-06 for UNKNOWN ULNA STEM NI manufactured by Zimmer Biomet, Inc..

Event Text Entries

[182338490] (b)(4). The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdrs are associated with this event. Please see associated reports: 0001822565 - 2020 - 00786.
Patient Sequence No: 1, Text Type: N, H10


[182338493] It was reported that a patient underwent an elbow arthroplasty approximately 10 years ago. The patient is being indicated for a revision due to alleged implant failure and possible implant fracture; however, no revision procedure has been reported to date. Attempts have been made and additional information is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001822565-2020-00778
MDR Report Key9797742
Report SourceCONSUMER,HEALTH PROFESSIONAL
Date Received2020-03-06
Date of Report2020-03-24
Date Mfgr Received2020-03-19
Date Added to Maude2020-03-06
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 ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1ZIMMER BIOMET, INC.
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN ULNA STEM
Generic NamePROSTHESIS, ELBOW
Product CodeJDB
Date Received2020-03-06
Model NumberNI
Catalog NumberNI
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER BIOMET, INC.
Manufacturer Address56 E. BELL DRIVE WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-06

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