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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREADED HOLE COVER; PROSTHESIS, HIP, SEMI-CONSTRAINED,UNCEMENTED,METAL/POLYMER,POROUS
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SMITH & NEPHEW, INC. REF THREADED HOLE COVER; PROSTHESIS, HIP, SEMI-CONSTRAINED,UNCEMENTED,METAL/POLYMER,POROUS Back to Search Results
Catalog Number 71336500
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Fever (1858); Pain (1994)
Date of Event 01/02/2018
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported a revision surgery was performed due to pain and fever, the tests were non conclusive of infection.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached the results of our investigation.(b)(4).
 
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Brand Name
REF THREADED 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 Key7184219
Report Number1020279-2018-00044
Device Sequence Number13710201
Product Code MBL
UDI-Device Identifier03596010197634
UDI-Public03596010197634
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K070756
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2009
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 03/06/2018
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 Date12/14/2018
Device Catalogue Number71336500
Device Lot Number08MM13629
Initial Date Received by Manufacturer 01/04/2018
Supplement Date Received by Manufacturer01/04/2018
Initial Report FDA Received Date01/11/2018
Supplement Report FDA Received Date03/06/2018
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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