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 company representative,health report with the FDA on 2019-03-04 for UNKNOWN HUMERAL COMPONENT N/A manufactured by Zimmer Biomet, Inc..

Event Text Entries

[137735809] (b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Unique identifier (udi) #: n/a. Concomitant medical products: unknown ulnar component; unknown articulation kit. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 00976, 0001825034 - 2019 - 00978.
Patient Sequence No: 1, Text Type: N, H10


[137735810] It was reported that the patient was indicated for an elbow revision due to unknown reasons. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5


[139245355] This follow-up report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10


[139245356] No further event information available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001825034-2019-00977
MDR Report Key8387602
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-03-04
Date of Report2019-03-19
Date Mfgr Received2019-03-19
Date Added to Maude2019-03-04
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 HUMERAL COMPONENT
Generic NamePROSTHESIS, ELBOW
Product CodeJDB
Date Received2019-03-04
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 2019-03-04

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