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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 58MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 58MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71335758
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Post Operative Wound Infection (2446)
Event Date 07/30/2018
Event Type  Injury  
Event Description
It was reported at first stage revision left hip, where the patient had infection. A revision hip was done originally on the (b)(6) 2017 after a periprosthetic fracture.
 
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Brand NameR3 20 DEG XLPE ACET LNR 36MM X 58MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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
sarah freestone
101 hessle road
hull HU3 2-BN
UK   HU3 2BN
MDR Report Key7773325
MDR Text Key116776034
Report Number1020279-2018-01510
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K023302
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71335758
Device Lot Number16MM17079
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 08/10/2018 Patient Sequence Number: 1
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