BIOLOX 76539155

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-02-18 for BIOLOX 76539155 manufactured by Smith & Nephew, Inc..

Event Text Entries

[3986026] It was reported that revision surgery was performed.
Patient Sequence No: 1, Text Type: D, B5


[11513405]
Patient Sequence No: 1, Text Type: N, H10


[11797962] It is unknown from the information provided if the observed metal transfer and deformation on these components were sustained during removal of the device or were due to impingement of the components in vivo. Bone ingrowth was observed on the acetabular cup.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1020279-2014-00101
MDR Report Key3632237
Report Source07
Date Received2014-02-18
Date of Report2014-01-30
Date of Event2014-01-30
Date Mfgr Received2014-01-30
Date Added to Maude2014-02-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMRS. MELANIE TRAVIS
Manufacturer Street1450 BROOKS ROAD
Manufacturer CityMEMPHIS TN 38116
Manufacturer CountryUS
Manufacturer Postal38116
Manufacturer Phone9013996233
Manufacturer G1SMITH & NEPHEW, INC.
Manufacturer Street1450 BROOKS ROAD
Manufacturer CityMEMPHIS TN 38116
Manufacturer CountryUS
Manufacturer Postal Code38116
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIOLOX
Generic NameFEMORAL COMPONENT
Product CodeLPF
Date Received2014-02-18
Catalog Number76539155
Lot Number11FT07486
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW, INC.
Manufacturer Address1450 BROOKS ROAD MEMPHIS TN 38116 US 38116


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2014-02-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.