ATTUNE FEMORAL IMPACTOR 2544-01-006 254401006

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 2020-03-25 for ATTUNE FEMORAL IMPACTOR 2544-01-006 254401006 manufactured by Depuy Ireland - 9616671.

Event Text Entries

[185053555] 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


[185053556] It was reported that the femoral impactor and rp ps insert trial was broken during surgery. All pieces were found and minimal time (1 minute) was added to surgery time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-09279
MDR Report Key9881134
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-25
Date of Report2020-03-09
Date of Event2020-03-09
Date Mfgr Received2020-03-09
Device Manufacturer Date2017-09-28
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
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street700 ORTHOPAEDIC DR.
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 NameATTUNE FEMORAL IMPACTOR
Generic NameATTUNE INSTRUMENTS : IMPACTORS
Product CodeHWA
Date Received2020-03-25
Model Number2544-01-006
Catalog Number254401006
Lot NumberAU5592231
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY IRELAND - 9616671
Manufacturer AddressLOUGHBEG RINGASKIDDY CO. CORK EI


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.