DURALOC CURVED CUP IMPACTOR 2244-08-000 224408000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-27 for DURALOC CURVED CUP IMPACTOR 2244-08-000 224408000 manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[185429575] Product complaint #: (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


[185429576] It was reported that while implanting the acetabular cup, the duralock curved cup impactor would not release from the modular piece that screws onto the cup. It is evident that the ball bearing on the end of the impactor was not working properly and that it needs replaced/fixed. Nothing broke off from the instrument. No surgical delay.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-09521
MDR Report Key9891526
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-27
Date of Report2020-03-11
Date of Event2020-03-11
Date Mfgr Received2020-03-26
Device Manufacturer Date2018-04-13
Date Added to Maude2020-03-27
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 ContactKARA DITTY-BOVARD
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal Code465810988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDURALOC CURVED CUP IMPACTOR
Generic NameHIP INSTRUMENTS : IMPACTORS
Product CodeHWA
Date Received2020-03-27
Model Number2244-08-000
Catalog Number224408000
Lot NumberSO2025945
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS INC US
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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