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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 PRIMARY LINERS CO; R3 44MM ID INTL COCR LINER 56MM
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SMITH & NEPHEW ORTHOPAEDICS LTD R3 PRIMARY LINERS CO; R3 44MM ID INTL COCR LINER 56MM Back to Search Results
Model Number 71335856
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 10/12/2014
Event Type  Injury  
Event Description
A revision surgery has been reported due to pain.
 
Manufacturer Narrative
 
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Brand Name
R3 PRIMARY LINERS CO
Type of Device
R3 44MM ID INTL COCR LINER 56MM
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
1 kingmaker court
gallows hill CV34 6WG
UK  CV34 6WG
Manufacturer (Section G)
SMITH & NEPHEW
aurora house
spa park
leamington spa CV31 3HL
UK   CV31 3HL
Manufacturer Contact
michael simmonds
oberneuhofstrasse 10d
baar
SZ   6340
4419264823
MDR Report Key4179727
MDR Text Key5092984
Report Number3005477969-2014-00534
Device Sequence Number1
Product Code NXT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Medical Assistant
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/30/2018
Device Model Number71335856
Device Catalogue Number71335856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/12/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/18/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
MODULAR SLEEVE -4MM 12/14: 74222100, LOT NI; BHR MODULAR HEAD 44MM: 74222144, LOT NI
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age75 YR
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