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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMF STEM WITH STIKTITE SZ 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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SMITH & NEPHEW, INC. SMF STEM WITH STIKTITE SZ 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 71352502
Medical Device Problem Code Unintended Movement (3026)
Health Effect - Clinical Code Pain (1994)
Date of Event 11/02/2015
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported the patient presented with a pre-operative diagnosis of failed right total hip arthroplasty with malpositioned femoral component and pain.Revision was performed to replace the acetabular cup, femoral component, and head.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached for the results of our investigation.
 
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Brand Name
SMF STEM WITH STIKTITE SZ 2
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6615875
Report Number1020279-2017-00398
Device Sequence Number90903
Product Code LPH
UDI-Device Identifier03596010619587
UDI-Public03596010619587
Combination Product (Y/N)N
Initial Reporter StateAL
Initial Reporter CountryUS
PMA/510(K) Number
K080625
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2015
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/23/2017
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 Date05/11/2023
Device Catalogue Number71352502
Device Lot Number13EM08539
Initial Date Received by Manufacturer 06/01/2017
Supplement Date Received by Manufacturer06/01/2017
Initial Report FDA Received Date06/06/2017
Supplement Report FDA Received Date10/23/2017
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
71332530/14CM13954; 71332535/14CM02031; 71335552/13MM04787; 71335752/14DM06961; 71343603/14AM19715A; 71352111/13JTM0018G
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age44 YR
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