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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RF INTERFIT ACET TH SZ 50 ACETABULAR SHELL

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SMITH & NEPHEW, INC. RF INTERFIT ACET TH SZ 50 ACETABULAR SHELL Back to Search Results
Catalog Number 71336050
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 12/16/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a revision hip surgery was performed to replace the cup, liner and femoral head due to infection.
 
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Brand NameRF INTERFIT ACET TH SZ 50
Type of DeviceACETABULAR SHELL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
robert rust
1450 brooks road
memphis, TN 38116
9013991624
MDR Report Key5352420
MDR Text Key35316454
Report Number1020279-2016-00030
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K960094
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71336050
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/22/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/07/2016 Patient Sequence Number: 1
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