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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN CEM FEM COMP SZ 11; PRSTHSS,HIP,SMICNSTRND,METALPOLYMER,CMNTD
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SMITH & NEPHEW, INC. SYN CEM FEM COMP SZ 11; PRSTHSS,HIP,SMICNSTRND,METALPOLYMER,CMNTD Back to Search Results
Catalog Number 71316011
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Information (3190)
Date of Event 10/19/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to remove the bipolar head.
 
Event or Problem Description
A revision surgery was reported due to an irrigation and débridement of the patient.No product failure reported.
 
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Brand Name
SYN CEM FEM COMP SZ 11
Common Device Name
PRSTHSS,HIP,SMICNSTRND,METALPOLYMER,CMNTD
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6994890
Report Number1020279-2017-00964
Device Sequence Number1051299
Product Code JDI
UDI-Device Identifier03596010410504
UDI-Public03596010410504
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K990369
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date (Section B) 01/03/2018
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 Date02/09/2026
Device Catalogue Number71316011
Device Lot Number16BM10068
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/20/2017
Supplement Date Received by Manufacturer10/20/2017
10/20/2017
Initial Report FDA Received Date11/01/2017
Supplement Report FDA Received Date11/02/2017
01/03/2018
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 Life Threatening; Required Intervention;
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