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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW R3; COCR ACETABULAR LINER
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SMITH & NEPHEW R3; COCR ACETABULAR LINER Back to Search Results
Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)
Patient Problems Necrosis (1971); Pain (1994); Swelling (2091); Tissue Damage (2104); Weakness (2145); Chemical Exposure (2570); Test Result (2695)
Event Date 08/07/2013
Event Type  Injury  
Event Description
It was reported that revision surgery was performed.Pain, weakness of the legs and hips, elevated cobalt and chromium levels, fluid accumulations around the hips, tissue damage, necrosis and exposure to metal debris reported.
 
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Brand Name
R3
Type of Device
COCR ACETABULAR LINER
Manufacturer (Section D)
SMITH & NEPHEW
1 kingmaker court
warwick technology park
warwick CV34 6WG
UK  CV34 6WG
Manufacturer (Section G)
SMITH & NEPHEW
1 kingmaker court
warwick technology park
warwick CV34 6WG
UK   CV34 6WG
Manufacturer Contact
michael simmonds
4419264823
MDR Report Key3601209
MDR Text Key4157400
Report Number3005477969-2014-00094
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 Consumer,Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 01/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/22/2014
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
FEMORAL HEAD, PART & LOT # UNKNOWN; ACETABULAR SHELL, PART & LOT # UNKNOWN
Patient Outcome(s) Hospitalization; Required Intervention;
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