DEPUY/CMW 2G 5450-32-500 545032500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-09 for DEPUY/CMW 2G 5450-32-500 545032500 manufactured by Depuy Cmw - 9610921.

Event Text Entries

[185730733] (b)(4). Initial reporter occupation: lawyer. 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


[185730734] On (b)(6) 2015, the patient underwent total right knee arthroplasty due to degenerative arthritis. The patella was resurfaced. The surgeon reported no intraoperative complications. The patient was implanted with the attune knee system and smartset bone cement x 2. On (b)(6) 2019, the patient underwent a right knee revision due to loosening of the tibial component, and pain. The surgeon indicated the tibial component was grossly loose, with de-bonding at the cement to component interface. He noted a well-fixed femoral component though it was revised. The patella was retained. The surgeon reported no intraoperative complications. The patient was implanted with a competitor system and there were no complications to the procedure. Doi: (b)(6) 2015, dor: (b)(6) 2019, (rt knee).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-01347
MDR Report Key9570899
Report SourceOTHER
Date Received2020-01-09
Date of Report2019-12-18
Date of Event2019-01-04
Date Mfgr Received2020-02-05
Device Manufacturer Date2014-04-30
Date Added to Maude2020-01-09
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 Street1210 WARD AVENUE
Manufacturer CityWEST CHESTER PA 193800988
Manufacturer CountryUS
Manufacturer Postal193800988
Manufacturer Phone6103142063
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 Received2020-01-09
Model Number5450-32-500
Catalog Number545032500
Lot Number7910366
Device Expiration Date2017-04-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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 2020-01-09

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