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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG +4 XLPE ACET LNR 40MM X 56OD PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. R3 20 DEG +4 XLPE ACET LNR 40MM X 56OD PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71338704
Device Problem Insufficient Information (3190)
Patient Problem Joint Dislocation (2374)
Event Type  Injury  
Event Description
It was reported that patient had primary thr in (b)(6) 2018 and due to a dislocation in (b)(6), an open reduction was performed.
 
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Brand NameR3 20 DEG +4 XLPE ACET LNR 40MM X 56OD
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
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key8226107
MDR Text Key132351946
Report Number1020279-2019-00100
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
PMA/PMN Number
K093363
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 04/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/19/2020
Device Catalogue Number71338704
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/21/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/08/2019 Patient Sequence Number: 1
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