UNKNOWN HUMERAL 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 2016-08-05 for UNKNOWN HUMERAL COMPONENT N/A manufactured by Zimmer Biomet, Inc..

Event Text Entries

[135218530] (b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00383.
Patient Sequence No: 1, Text Type: N, H10


[135218531] It was reported that the patient was patient underwent a revision procedure due to massive bone loss. No additional information is available form this event
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1822565-2019-00379
MDR Report Key5850775
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2016-08-05
Date of Report2019-02-06
Date of Event2018-10-05
Date Mfgr Received2016-08-03
Date Added to Maude2016-08-05
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 Report0

Device Details

Brand NameUNKNOWN HUMERAL COMPONENT
Generic NamePROSTHESIS, ELBOW
Product CodeKWJ
Date Received2016-08-05
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 2016-08-05

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