INTERCHANGEABLE ULNAR ASSEMBLY FOR CEMENTED USE ONLY N/A 32810505302

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-12-30 for INTERCHANGEABLE ULNAR ASSEMBLY FOR CEMENTED USE ONLY N/A 32810505302 manufactured by Zimmer Biomet, Inc..

Event Text Entries

[173252859] (b)(4). Report source: foreign: (b)(6). It is unknown if product will be returning to zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[173252860] It was reported patient has been indicated for revision due to unknown reasons. No revision has been reported to date. Attempts to obtain additional information have been made; however, no more is available at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001822565-2019-05496
MDR Report Key9532080
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-12-30
Date of Report2020-03-11
Date Mfgr Received2020-02-13
Device Manufacturer Date2017-12-22
Date Added to Maude2019-12-30
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 NameINTERCHANGEABLE ULNAR ASSEMBLY FOR CEMENTED USE ONLY
Generic NameELBOW, PROSTHESIS
Product CodeJDC
Date Received2019-12-30
Model NumberN/A
Catalog Number32810505302
Lot Number63710279
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 2019-12-30

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