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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 -3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM -3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Model Number 71343603
Medical Device Problem Code Loose or Intermittent Connection (1371)
Health Effect - Clinical Code Injury (2348)
Date of Event 03/27/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that patient had smith+nephew components since (b)(6) 2019.A revision surgery was performed on (b)(6) 2020 due to instability and chronic dislocations.The cup, liner and femoral head were removed.
 
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Brand Name
OXINIUM FEM HD 12/14 36 MM -3
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9974977
Report Number1020279-2020-01319
Device Sequence Number2176878
Product Code JDI
UDI-Device Identifier03596010000675
UDI-Public03596010000675
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K022958
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 12/15/2020
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 Number71343603
Device Catalogue Number71343603
Device Lot Number18HM00725
Initial Date Received by Manufacturer 03/27/2020
Supplement Date Received by Manufacturer12/14/2020
Initial Report FDA Received Date04/17/2020
Supplement Report FDA Received Date12/15/2020
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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