DEPUY/CMW 2G 545032500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-01-03 for DEPUY/CMW 2G 545032500 manufactured by Depuy Cmw - 9610921.

Event Text Entries

[173773883] (b)(4). Initial reporter occupation: lawyer. (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


[173773884] Patient was revised to address tibial loosening at the bone to aseptic cement interface. Depuy cement manufacturer. Baseplate well fixed to cement. It was also reported that patient has high bmi and physician believes patient needed longer tibial stem, revised to attune revision rp. Doi: (b)(6) 2016; doi: (b)(6) 2018; left knee.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-00272
MDR Report Key9545053
Report SourceCOMPANY REPRESENTATIVE,OTHER
Date Received2020-01-03
Date of Report2018-05-14
Date of Event2018-05-14
Date Mfgr Received2019-12-10
Device Manufacturer Date2015-10-07
Date Added to Maude2020-01-03
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 ContactKARA DITTY-BOVARD
Manufacturer Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1DEPUY CMW - 9610921
Manufacturer StreetCORNFORD RD
Manufacturer CityBLACKPOOL FY4 4QQ
Manufacturer CountryUK
Manufacturer Postal CodeFY4 4QQ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDEPUY/CMW 2G
Generic NameBONE CEMENT : BONE CEMENT
Product CodeMBB
Date Received2020-01-03
Catalog Number545032500
Lot Number8143802
Device Expiration Date2018-06-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY CMW - 9610921
Manufacturer AddressCORNFORD RD BLACKPOOL FY4 4QQ UK FY4 4QQ


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-03

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