COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING 44MM N/A 115340

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 2018-08-07 for COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING 44MM N/A 115340 manufactured by Zimmer Biomet, Inc..

Event Text Entries

[116364632] (b)(4). Concomitant medical products: 113647 comp primary stem 7mm std 553200, xl-115363 arcom xl 44-36 std hmrl brng 019320, 115310 comp rvrs shldr glnsp std 36mm 242610, 180511 comp non-lckng screw 4. 75x35mm 288050, 115330 comp rvrs shdr glen bsplt +ha 177750, 118001 versa-dial/comp ti std taper 685290, 115383 comp rvs cntrl scr 6. 5x35mm st 245440, 180504 comp locking screw 4. 75x35mm 436280, 180511 comp non-lckng screw 4. 75x35mm 852740. The investigation is in progress. Once the investigation is completed a follow up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[116364633] It was reported the patient underwent a reverse total shoulder arthroplasty revision due to pain and a humeral tray fracture, approximately seven (7) years post primary surgery. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001825034-2018-06136
MDR Report Key7758329
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2018-08-07
Date of Report2019-01-16
Date of Event2016-12-01
Date Mfgr Received2019-01-10
Device Manufacturer Date2009-10-19
Date Added to Maude2018-08-07
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 NumberZ-1103-2017
Event Type3
Type of Report3

Device Details

Brand NameCOMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING 44MM
Generic NamePROSTHESIS, SHOULDER
Product CodePAO
Date Received2018-08-07
Model NumberN/A
Catalog Number115340
Lot Number257020
Device Expiration Date2019-10-31
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 2018-08-07

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