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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM +0 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED

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SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM +0 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED Back to Search Results
Catalog Number 71343200
Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Patient Problems Injury (2348); Joint Dislocation (2374)
Event Date 06/08/2018
Event Type  Injury  
Event Description

Revision surgery was performed due to dislocation. The surgeon does not fault the device. The product is not available. No more information available.

 
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Brand NameOXINIUM FEM HD 12/14 32MM +0
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah freestone
101 hessle road
hull HU3 2-BN
UK   HU3 2BN
MDR Report Key7712732
MDR Text Key114796610
Report Number1020279-2018-01353
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK021673
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/07/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/23/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device Catalogue Number71343200
Device LOT Number16GM04571
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/23/2018 Patient Sequence Number: 1
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