ACCLAIM LINKED POLY HUM YOKE 172285000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-06-12 for ACCLAIM LINKED POLY HUM YOKE 172285000 manufactured by Depuy Orthopaedics, Inc. 1818910.

MAUDE Entry Details

Report Number1818910-2019-95777
MDR Report Key8691444
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-06-12
Date of Report2019-05-22
Date of Event2019-05-22
Date Mfgr Received2019-07-17
Device Manufacturer Date2005-04-25
Date Added to Maude2019-06-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. KARA DITTY-BOVARD
Manufacturer Street1210 WARD AVENUE
Manufacturer CityWEST CHESTER PA 193800988
Manufacturer CountryUS
Manufacturer Postal193800988
Manufacturer Phone6107428552
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465820988
Manufacturer CountryUS
Manufacturer Postal Code465820988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACCLAIM LINKED POLY HUM YOKE
Generic NameACCLAIM ELBOW IMPLANT : ELBOW HUMERAL YOKE
Product CodeJDB
Date Received2019-06-12
Catalog Number172285000
Lot NumberZP8B41000
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-06-12

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