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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM +4; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
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SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM +4; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT Back to Search Results
Model Number 71342804
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Injury (2348)
Date of Event 09/13/2010
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported a left hip revision surgery was performed due to the patient suffering from a right hip dislocation.The patient had a history of multiple dislocations occurring on the same hip side.
 
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Brand Name
OXINIUM FEM HD 12/14 28MM +4
Common Device Name
PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9928561
Report Number1020279-2020-01163
Device Sequence Number2818347
Product Code LZO
UDI-Device Identifier03596010474162
UDI-Public03596010474162
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K021673
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2010
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date05/01/2019
Device Model Number71342804
Device Catalogue Number71342804
Device Lot Number09AM03884
Initial Date Received by Manufacturer 03/11/2020
Supplement Date Received by Manufacturer12/13/2020
Initial Report FDA Received Date04/06/2020
Supplement Report FDA Received Date12/16/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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