UNKNOWN LINER 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 LINER N/A manufactured by Zimmer Biomet, Inc..

Event Text Entries

[186556418] (b)(4). Concomitant medical products: unknown-unknown head-unknown, unknown-unknown stem-unknown, unknown-unknown cup-unknown. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 01331. Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Device remains implanted.
Patient Sequence No: 1, Text Type: N, H10


[186556419] It was reported patient has been indicated for revision due to unknown reasons. No revision has been reported to date. Attempts to obtain additional information have been made; however, no more is available at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001825034-2020-01333
MDR Report Key9897150
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2020-03-30
Date of Report2020-03-30
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 NumberNI
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN LINER
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. Other 2020-03-30

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