UNKNOWN COONRAD-MORREY HUMERAL STEM N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-14 for UNKNOWN COONRAD-MORREY HUMERAL STEM N/A manufactured by Zimmer Biomet, Inc..

Event Text Entries

[117123672] (b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation at this time. Device location is unknown with limited information available and it is unknown if the patient has been revised. 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: 0001822565-2018-04413. Patient not yet revised.
Patient Sequence No: 1, Text Type: N, H10


[117123673] It was reported the patient underwent initial elbow arthroplasty on an unknown date. Subsequently, patient has been indicated for an elbow revision procedure due to unknown reasons. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5


[134341338] (b)(4). Reported event was unable to be confirmed due to limited information received from the customer. As per x-ray review, there is severe loosening of the humeral component of a left total elbow arthroplasty which lead to development of a fracture of the distal humeral diaphysis. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. 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


[134341339] No further event information available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001822565-2018-04412
MDR Report Key7783279
Date Received2018-08-14
Date of Report2019-01-28
Date Mfgr Received2019-01-24
Date Added to Maude2018-08-14
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 NameUNKNOWN COONRAD-MORREY HUMERAL STEM
Generic NamePROSTHESIS, ELBOW
Product CodeJDB
Date Received2018-08-14
Model NumberN/A
Catalog NumberNI
Lot NumberNI
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. Required No Informationntervention 2018-08-14

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