CUSTOM LT IBP MED HUMERAL COMP N/A CP560539

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2019-03-18 for CUSTOM LT IBP MED HUMERAL COMP N/A CP560539 manufactured by Zimmer Biomet, Inc..

Event Text Entries

[139092206] (b)(4). Concomitant medical products: 114368 ibp ulna left std intlk 221552. The complaint is under investigation. Once the investigation is completed a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[139092207] It was reported that the patient underwent an initial left elbow arthroplasty and subsequently was revised due to unknown reasons approximately ten (10) years post-implantation. No additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001825034-2019-01117
MDR Report Key8429227
Report SourceCONSUMER,HEALTH PROFESSIONAL
Date Received2019-03-18
Date of Report2019-06-14
Date of Event2012-05-16
Date Mfgr Received2019-06-10
Device Manufacturer Date2002-07-01
Date Added to Maude2019-03-18
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 NameCUSTOM LT IBP MED HUMERAL COMP
Generic NamePROSTHESIS, ELBOW
Product CodeJDB
Date Received2019-03-18
Model NumberN/A
Catalog NumberCP560539
Lot Number750420
Device Expiration Date2012-07-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2019-03-18

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