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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 25MM; PRSTHSS,HIP,SMCNSTRND,UNCMNTD,MTL/PLYMR,NNPRS,CLICMPHSPHT
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SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 25MM; PRSTHSS,HIP,SMCNSTRND,UNCMNTD,MTL/PLYMR,NNPRS,CLICMPHSPHT Back to Search Results
Catalog Number 71332525
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Injury (2348)
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to unknown reasons.
 
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 SPHER HEAD SCREW 25MM
Common Device Name
PRSTHSS,HIP,SMCNSTRND,UNCMNTD,MTL/PLYMR,NNPRS,CLICMPHSPHT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7133845
Report Number1020279-2017-01296
Device Sequence Number13780761
Product Code MEH
UDI-Device Identifier03596010460462
UDI-Public03596010460462
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K990666
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Patient
Type of Report Initial,Followup
Report Date (Section B) 02/24/2018
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 Lay User/Patient
Device Expiration Date05/29/2022
Device Catalogue Number71332525
Device Lot Number12EM00062
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/27/2017
Supplement Date Received by Manufacturer11/27/2017
Initial Report FDA Received Date12/20/2017
Supplement Report FDA Received Date02/24/2018
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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