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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 56MM; ACETABULAR HIP PROSTHESIS
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SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 56MM; ACETABULAR HIP PROSTHESIS Back to Search Results
Catalog Number 71335756
Device Problem Leak/Splash (1354)
Patient Problems Purulent Discharge (1812); Sepsis (2067)
Event Date 04/21/2015
Event Type  Injury  
Event Description
It was reported that a revision was performed due to a leaking wound, sepsis and a poly exchange.
 
Manufacturer Narrative
(b)(4).No product was returned, hence visual or dimensional inspection could not be completed.No lot number was provided; hence dhr could not be completed.If more information is received, this investigation will be reopened.
 
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Brand Name
R3 20 DEG XLPE ACET LNR 36MM X 56MM
Type of Device
ACETABULAR HIP PROSTHESIS
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 Key4757302
MDR Text Key16564110
Report Number1020279-2015-00251
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K070756
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative,company representati
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number71335756
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/21/2015
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age62 YR
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