UNKNOWN COONRAD-MORREY ULNAR COMPONENT N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-08-24 for UNKNOWN COONRAD-MORREY ULNAR COMPONENT N/A manufactured by Zimmer Biomet, Inc..

Event Text Entries

[118128147] (b)(4). Additional concomitant medical products: unknown coonrad-morrey humeral component. The complaint is under investigation. Once the investigation is completed a follow up report will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2018 -04655.
Patient Sequence No: 1, Text Type: N, H10


[118128148] It was reported that the patient underwent a revision right elbow arthroplasty, and was subsequently revised due to humeral and ulnar loosening, and ulnar peri-prosthetic fracture and bone loss approximately 2 years, 8 months post-implantation. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001822565-2018-04656
MDR Report Key7812948
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2018-08-24
Date of Report2018-09-27
Date of Event2011-06-16
Date Mfgr Received2018-08-28
Date Added to Maude2018-08-24
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
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN COONRAD-MORREY ULNAR COMPONENT
Generic NamePROSTHESIS, ELBOW
Product CodeJDB
Date Received2018-08-24
Model NumberN/A
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. Hospitalization; 2. Required No Informationntervention 2018-08-24

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