MODULAR FEMORAL STEM CALCICOAT CERAMIC COATING SIZE 9 N/A 65771300900

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-03-25 for MODULAR FEMORAL STEM CALCICOAT CERAMIC COATING SIZE 9 N/A 65771300900 manufactured by Zimmer Biomet, Inc..

Event Text Entries

[186509484] (b)(4). Concomitant medical products: 00784801300 m/l kinectiv strt neck p 61269206, 0100181500 durom metasul hd 50 cde p 2472890, 0100185146 hd adapt m/0 12/14 18/20 2514226, 0100214056 durom cup 56/p 289 2477612. Report source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The product was retained by the hospital and it's location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[186509485] It was reported the patient underwent an initial tha and was revised ten years later due to pain and femoral stem fracture. Attempts were made to obtain additional information; however, none was available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001822565-2020-00951
MDR Report Key9880394
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2020-03-25
Date of Report2020-04-03
Date of Event2020-03-05
Date Mfgr Received2020-03-31
Device Manufacturer Date2010-06-21
Date Added to Maude2020-03-25
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 NameMODULAR FEMORAL STEM CALCICOAT CERAMIC COATING SIZE 9
Generic NamePROSTHESIS, HIP
Product CodeMEH
Date Received2020-03-25
Model NumberN/A
Catalog Number65771300900
Lot Number61487872
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. Hospitalization; 2. Required No Informationntervention 2020-03-25

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