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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3; COCR ACETABULAR LINER
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SMITH & NEPHEW ORTHOPAEDICS LTD R3; COCR ACETABULAR LINER Back to Search Results
Catalog Number 71335850
Device Problem Metal Shedding Debris (1804)
Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414)
Event Date 02/05/2015
Event Type  Injury  
Event Description
It was reported that revision surgery was performed due to an adverse reaction to metal debris and soft tissue reaction seen on ct scan.The patient reportedly needed to use stick after 50 yards walk.
 
Manufacturer Narrative
 
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Brand Name
R3
Type of Device
COCR ACETABULAR LINER
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
1 kingmaker court
gallows hill CV34 6WG
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK   CV31 3HL
Manufacturer Contact
terry mcmahon
970 lake carillon drive
st. petersburg, FL 33716
4419264823
MDR Report Key4708856
MDR Text Key5647094
Report Number3005477969-2015-00121
Device Sequence Number1
Product Code NXT
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,foreign,health professi
Reporter Occupation Other
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/29/2018
Device Catalogue Number71335850
Device Lot Number08CW15958 033
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received04/15/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2008
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, # 74222100, LOT # NI
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age69 YR
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