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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 38MM ID US COCR LNR 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD R3 38MM ID US COCR LNR 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 71341150
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cyst(s) (1800); Pain (1994); Toxicity (2333); Injury (2348)
Event Date 05/14/2014
Event Type  Injury  
Event Description
It was reported that left hip revision surgery was performed due to metallosis, pain, evidence of super acetabular cyst formation, elevated serum cobalt levels and functional limitations.
 
Manufacturer Narrative
It was reported that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.As no device part and batch numbers were provided for investigation, a complaint history review manufacturing record review, device labelling review and risk management review could not be performed.If more information is received, this investigation will be reopened.No medical records or evidence have been received on this complaint.The reported event cannot be assessed and a thorough medical assessment cannot be performed.When notification is received that additional medical documentation has been provided, this complaint will be re-evaluated and a thorough medical assessment rendered.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
 
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Brand Name
R3 38MM ID US COCR LNR 50MM
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK  CV31 3HL
MDR Report Key8533733
MDR Text Key142594771
Report Number3005975929-2019-00169
Device Sequence Number1
Product Code NXT
Combination Product (y/n)N
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 04/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number71341150
Date Manufacturer Received04/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
71331950 R3 3 HOLE HA CTD ACET SHELL 50MM; 74122538 HEMI HEAD 38MM L#UNK; 74222100 MODULAR SLEEVE -4MM 12/14; ACETABULAR CUP, LOT AND PART# UNKNOWN; FEMORAL HEAD, LOT AND PART# UNKNOWN; P#UNK MEMPHIS HIP IMPLANT L#UNK QTY#2
Patient Outcome(s) Hospitalization; Required Intervention;
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