VERSA-DIAL GLENOSPHERE STANDARD N/A 115320

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-08-24 for VERSA-DIAL GLENOSPHERE STANDARD N/A 115320 manufactured by Zimmer Biomet, Inc..

Event Text Entries

[118124059] (b)(4). Concomitant medical products: 113650,comprehensive humeral stem, 887520. The 010000589,comprehensive mini baseplate and taper adaptor, 314230. Xl-115368,arcomxl retentive +3 mm humeral bearing, 976440. The 115370,cobalt chrome standard humeral tray, 005740. 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: 0001825034-2018-08529, 0001825034-2018-08531, 0001825034-2018-08533, 0001825034-2018-08534. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[118124060] It was reported the patient underwent a left reverse total shoulder arthroplasty revision surgery due to unknown reasons, approximately three (3) weeks following prior shoulder revision. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001825034-2018-08532
MDR Report Key7812868
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2018-08-24
Date of Report2019-02-21
Date of Event2017-08-02
Date Mfgr Received2019-02-05
Device Manufacturer Date2017-05-02
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 NameVERSA-DIAL GLENOSPHERE STANDARD
Generic NamePROSTHESIS, SHOULDER
Product CodePAO
Date Received2018-08-24
Model NumberN/A
Catalog Number115320
Lot Number073170
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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