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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 L/+8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM L/+8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Model Number 71343608
Medical Device Problem Code Loose or Intermittent Connection (1371)
Health Effect - Clinical Code Injury (2348)
Date of Event 04/01/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient had fluid building up under his closed hip wound, following a thr.Additionally, the patient reported a feeling of small laxity in his soft tissues.The event was resolved via revision surgery, where the oxinium head was changed from a +8 to a +12.
 
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Brand Name
OXINIUM FEM HD 12/14 36 MM L/+8
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9919463
Report Number1020279-2020-01130
Device Sequence Number3375263
Product Code JDI
UDI-Device Identifier03596010477293
UDI-Public03596010477293
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K022958
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 12/06/2020
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 Model Number71343608
Device Catalogue Number71343608
Device Lot Number19BM16418
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/01/2020
Supplement Date Received by Manufacturer12/02/2020
Initial Report FDA Received Date04/03/2020
Supplement Report FDA Received Date12/06/2020
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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