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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 Codes Deposits (1809); Failure of Implant (1924); Unspecified Infection (1930); Toxicity (2333); Fibrosis (3167)
Date of Event 09/30/2015
Type of Reportable Event Serious Injury
Event or Problem Description
The patient presented with a preoperative diagnosis of right hip infection.The patient underwent a removal of the right total hip arthroplasty and placement of antibiotic impregnated cement spacer.
 
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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 Key6789965
Report Number1020279-2017-00622
Device Sequence Number18864545
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) 11/17/2017
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 Health Professional
Device Expiration Date10/11/2020
Device Catalogue Number71343612
Device Lot Number10KM10352
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 Date11/17/2017
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
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