UNKNOWN CUP N/A

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 2020-03-30 for UNKNOWN CUP N/A manufactured by Zimmer Biomet, Inc..

Event Text Entries

[186549750] (b)(4). Implanted sometime in 1990. Reported event was unable to be confirmed. X-rays reviewed by a third party hcp notes possible fracture and undersized cup component. Dhr was unable to be reviewed as the lot number for the device is unavailable. The root cause is unable to be determined due to limited information provided by the customer.
Patient Sequence No: 1, Text Type: N, H10


[186549751] It was reported that patient underwent a left hip revision approximately 30 years post implantation due to severe bone loss and proximal migration of the cup component. Attempts have been made and additional information on the reported event is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001822565-2020-01129
MDR Report Key9897757
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-11
Date Mfgr Received2020-03-05
Date Added to Maude2020-03-30
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 NameUNKNOWN CUP
Generic NamePROSTHESIS, HIP
Product CodeJDI
Date Received2020-03-30
Model NumberN/A
Catalog NumberNI
Lot NumberNI
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 2020-03-30

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