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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 52MM PRSTHSIS, HIP, SMI-CNSTRIND, UNCMNTD, MTL/PLMER, PR

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SMITH AND NEPHEW, INC. R3 3 HOLE ACET SHELL 52MM PRSTHSIS, HIP, SMI-CNSTRIND, UNCMNTD, MTL/PLMER, PR Back to Search Results
Catalog Number 71335552
Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Local Reaction (2035); Injury (2348)
Event Date 03/19/2019
Event Type  Injury  
Event Description
It was reported that a revision surgery from the right hip was performed due to pain, adverse local tissue reaction, fluid build up.
 
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Brand NameR3 3 HOLE ACET SHELL 52MM
Type of DevicePRSTHSIS, HIP, SMI-CNSTRIND, UNCMNTD, MTL/PLMER, PR
Manufacturer (Section D)
SMITH AND NEPHEW, INC.
1450 brooks road
spa park
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK CV31 3HL
Manufacturer Contact
holly topping
1450 brooks road
38116
memphis, TN 
5123913905
MDR Report Key8996105
MDR Text Key157727976
Report Number3005975929-2019-00327
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070756
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/11/2022
Device Catalogue Number71335552
Device Lot Number12CM08257
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2020
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: 09/11/2019 Patient Sequence Number: 1
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