UNKNOWN DEPUY CEMENT UNK-KNEE

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 2017-10-25 for UNKNOWN DEPUY CEMENT UNK-KNEE manufactured by Depuy Cmw ? 9610921.

Event Text Entries

[90169606] Complete product detail has not been received at this time. If further information is received a follow-up medwatch will be filed as appropriate. 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


[90169607] Patient was revised to address loosening of the tibial component at the cement to implant interface. Depuy cement was used. It was noted that patient fell several times.
Patient Sequence No: 1, Text Type: D, B5


[105782130] No device associated with this report was received for examination. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Depuy considers the investigation closed at this time. Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. 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


MAUDE Entry Details

Report Number1818910-2017-27380
MDR Report Key6975724
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2017-10-25
Date of Report2017-09-26
Date of Event2017-09-26
Date Mfgr Received2017-11-06
Date Added to Maude2017-10-25
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 ContactCHAD GIBSON
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 46581
Manufacturer CountryUS
Manufacturer Postal46581
Manufacturer Phone5743725905
Manufacturer G1DEPUY CMW
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 NameUNKNOWN DEPUY CEMENT
Generic NameCEMENT / CEMENT ACCESSORY
Product CodeLZN
Date Received2017-10-25
Catalog NumberUNK-KNEE
Lot NumberUNKNOWN
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 2017-10-25

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