C/M ELBOW ULNAR N/A 32810505301

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-16 for C/M ELBOW ULNAR N/A 32810505301 manufactured by Zimmer Biomet, Inc..

Event Text Entries

[100397741] (b)(4). Multiple mdr reports were filed for this event. Please also see associated report(s): 0001822565 - 2018 - 00973. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[100397742] It was report the patient was revised to address implant fracture. No further information has been made available at this time.
Patient Sequence No: 1, Text Type: D, B5


[132371497] This follow-up report is being submitted to relay additional information. Additional:updated corrected device (b)(4). Interchangeable humeral assembly for cemented use only small 62774244 reported event was confirmed by review of x-rays provided. Per the review, "fractured left elbow arthroplasty. Lucencies along the humeral and ulnar components consistent with loosening. Dhr was reviewed and no discrepancies were found. 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


[132371498]
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001822565-2018-00974
MDR Report Key7278590
Date Received2018-02-16
Date of Report2018-05-23
Date of Event2017-09-20
Date Mfgr Received2018-05-18
Device Manufacturer Date2014-10-28
Date Added to Maude2018-02-16
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 Report0

Device Details

Brand NameC/M ELBOW ULNAR
Generic NamePROSTHESIS, EXTREMITY
Product CodePAE
Date Received2018-02-16
Model NumberN/A
Catalog Number32810505301
Lot Number62818043
ID NumberN/A
Device Expiration Date2019-10-31
OperatorPHYSICIAN
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 2018-02-16

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