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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM XL/+12; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
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SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM XL/+12; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER Back to Search Results
Catalog Number 71343612
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Wound Dehiscence (1154)
Date of Event 09/17/2015
Type of Reportable Event Serious Injury
Event or Problem Description
The patient presented with right hip drainage and underwent an excisional debridement, exchange of acetabular liner, exchange of femoral ball.
 
Additional Manufacturer Narrative
Please review attached for the investigation results.(b)(4).
 
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Brand Name
OXINIUM FEM HD 12/14 36 MM XL/+12
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6789966
Report Number1020279-2017-00621
Device Sequence Number139236
Product Code LZO
UDI-Device Identifier03596010520449
UDI-Public03596010520449
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K021673
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2015
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date (Section B) 11/16/2017
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 Hospital Service Technician
Device Expiration Date03/24/2022
Device Catalogue Number71343612
Device Lot Number12CM16522
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/14/2017
Supplement Date Received by Manufacturer07/14/2017
Initial Report FDA Received Date08/11/2017
Supplement Report FDA Received Date11/16/2017
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;
Patient Age53 YR
Patient Weight76
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