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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. R3 3 HOLE ACET SHELL 60MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH AND NEPHEW, INC. R3 3 HOLE ACET SHELL 60MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71335560
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 08/29/2018
Event Type  Injury  
Event Description
It was reported that a hip revision was performed due to delayed hip prosthesis infection.
 
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Brand NameR3 3 HOLE ACET SHELL 60MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH AND NEPHEW, INC.
1450 brooks road
memphis, tennessee
memphis 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, tennessee
memphis 38116
MDR Report Key7954123
MDR Text Key123352199
Report Number1020279-2018-02143
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K070756
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 01/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71335560
Device Lot Number15KW08569
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 Received09/17/2018
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 Treatment Data
Date Received: 10/10/2018 Patient Sequence Number: 1
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