ACETLR CUP HAP 58MM W/ IMPTR 74120158

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2019-11-29 for ACETLR CUP HAP 58MM W/ IMPTR 74120158 manufactured by Smith & Nephew Orthopaedics Ltd.

MAUDE Entry Details

Report Number3005975929-2019-00421
MDR Report Key9391991
Report SourceFOREIGN,OTHER
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2010-08-26
Date Mfgr Received2019-11-01
Device Manufacturer Date2008-06-05
Date Added to Maude2019-11-29
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 ContactDR. SARAH FREESTONE
Manufacturer G1SMITH & NEPHEW ORTHOPAEDICS LTD
Manufacturer StreetAURORA HOUSE SPA PARK
Manufacturer CityLEAMINGTON SPA CV313HL
Manufacturer CountryUK
Manufacturer Postal CodeCV31 3HL
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACETLR CUP HAP 58MM W/ IMPTR
Generic NamePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
Product CodeNXT
Date Received2019-11-29
Catalog Number74120158
Lot Number088776
Device Expiration Date2013-05-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW ORTHOPAEDICS LTD
Manufacturer AddressAURORA HOUSE SPA PARK LEAMINGTON SPA CV313HL UK CV31 3HL


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-11-29

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