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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF INTERFIT THRD HOLE COVER; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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SMITH & NEPHEW, INC. REF INTERFIT THRD HOLE COVER; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71330001
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 11/24/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that patient underwent revision surgery due to infection, which involved removal of all implants.
 
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Brand Name
REF INTERFIT THRD HOLE COVER
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7058458
Report Number1020279-2017-01118
Device Sequence Number2037265
Product Code MBL
UDI-Device Identifier03596010196590
UDI-Public03596010196590
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K960094
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/27/2017
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 Date01/29/2023
Device Catalogue Number71330001
Device Lot Number13AM18509
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/24/2017
Initial Report FDA Received Date11/27/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ANTHOLOGY HO POR PL HA SZ 7/71357107/12CM17388; COCR 12/14 FEM HD 32 + 8/71303208/13CT29132; REF SPHER HEAD SCREW 25MM/71332525/13DM20055; REF SPHER HEAD SCREW 35MM/71332535/13KM12354; REF THREE HOLE SHELL 58MM/71336458/12LM00109; REF XLPE 32 20 DEG 58-60 G/71333336/13GM03556
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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