ATTUNE CR FEM LT SZ 6 CEM 1504-00-106 150400106

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 2020-03-31 for ATTUNE CR FEM LT SZ 6 CEM 1504-00-106 150400106 manufactured by Depuy Ireland - 9616671.

Event Text Entries

[185895203] (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


[185895204] It was reported that the sales rep was notified that the patient had an infected left knee. The surgical removal of implants was planned for on an urgent basis on this day. Surgery was performed implants were removed and a prostalac knee spacer was implanted. Doi: (b)(6) 2018, (b)(6) 2019 (insert). Dor: (b)(6) 2020, left knee.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-09804
MDR Report Key9907906
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-16
Date of Event2020-03-16
Date Mfgr Received2020-03-16
Device Manufacturer Date2018-08-01
Date Added to Maude2020-03-31
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 IRELAND - 9616671
Manufacturer StreetLOUGHBEG RINGASKIDDY CO.
Manufacturer CityCORK
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameATTUNE CR FEM LT SZ 6 CEM
Generic NameATTUNE IMPLANT : KNEE FEMORAL
Product CodeJWH
Date Received2020-03-31
Model Number1504-00-106
Catalog Number150400106
Lot Number8871287
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
101. Required No Informationntervention 2020-03-31

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