UNK ZIMMER BIGLIANI FLATOW SEE NARRATIVE IN H10

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-30 for UNK ZIMMER BIGLIANI FLATOW SEE NARRATIVE IN H10 manufactured by Zimmer Biomet, Inc..

Event Text Entries

[186553705] (b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 01179. Udi# (b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10


[186553706] It was reported by that the patient underwent an initial right shoulder arthroplasty at an unknown date. Subsequently the patient has been indicated for a revision, however, a revision has not been reported. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001822565-2020-01178
MDR Report Key9900849
Report SourceDISTRIBUTOR
Date Received2020-03-30
Date of Report2020-03-30
Date Mfgr Received2020-03-09
Date Added to Maude2020-03-30
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
Removal Correction NumberNI
Event Type3
Type of Report3

Device Details

Brand NameUNK ZIMMER BIGLIANI FLATOW
Generic NamePROSTHESIS, EXTREMITIES
Product CodeHSD
Date Received2020-03-30
Model NumberNI
Catalog NumberSEE NARRATIVE IN H10
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2020-03-30

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