COMP RVS CNTRL 6.5X30MM ST/RST 115396

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 2019-02-11 for COMP RVS CNTRL 6.5X30MM ST/RST 115396 manufactured by Zimmer Biomet, Inc..

Event Text Entries

[135738951] (b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Hospital would not return fx portion.
Patient Sequence No: 1, Text Type: N, H10


[135738952] It was reported that during a comprehensive reverse total shoulder the central screw; manufactured of implant grade material, was broken upon insertion. The patient retained the fractured portion. No medical intervention, adverse impact on the patient, or delay to surgery. No further information is available at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001825034-2019-00499
MDR Report Key8324997
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2019-02-11
Date of Report2019-04-24
Date of Event2019-01-31
Date Mfgr Received2019-04-22
Device Manufacturer Date2018-10-15
Date Added to Maude2019-02-11
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 NameCOMP RVS CNTRL 6.5X30MM ST/RST
Generic NamePROSTHESIS, EXTREMITY
Product CodePAO
Date Received2019-02-11
Catalog Number115396
Lot Number028720
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
10 2019-02-11

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