ACETABLR CUP HAP

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 2020-03-31 for ACETABLR CUP HAP manufactured by Smith & Nephew Orthopaedics Ltd.

Event Text Entries

[185893278] It was reported that a left hip revision was performed due to severe pain; decreased mobility; shedding of metal debris into the bloodstream; tissue damage; and elevated cobalt and chromium levels.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005975929-2020-00095
MDR Report Key9908389
Report SourceOTHER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2017-08-23
Date Mfgr Received2020-03-04
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
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 NameACETABLR CUP HAP
Generic NamePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
Product CodeNXT
Date Received2020-03-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2020-03-31

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