PLUS ED75004169

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 2011-04-18 for PLUS ED75004169 manufactured by Smith & Nephew, Inc. Aarau Switzerland.

Event Text Entries

[1857418] It was reported that revision surgery was performed due to pain and fracture of the device.
Patient Sequence No: 1, Text Type: D, B5


[9241440] Based on the investigation performed at (b)(4) the root cause of the reported breakage of the ceramic ball head after more than ten years in situ could not be estabilshed conclusively. With respect to the time of function of the implant it is believed that no implant related factors contributed to the breakage.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9613369-2011-00020
MDR Report Key2061111
Report Source*,07
Date Received2011-04-18
Date of Report2011-03-03
Date of Event2011-02-28
Date Mfgr Received2011-03-03
Date Added to Maude2011-06-01
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 G1AARAU SWITZERLAND MANUFACTURING SITE
Manufacturer StreetSCHACHENALLEE 29
Manufacturer CityAARAU
Manufacturer CountrySZ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePLUS
Generic NameFEMORAL HEAD
Product CodeLPF
Date Received2011-04-18
Model NumberED75004169
Catalog NumberED75004169
Lot Number9912.15.3235
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW, INC. AARAU SWITZERLAND
Manufacturer AddressSCHACHENALLEE 29 AARAU


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2011-04-18

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