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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 54MM PRSTHSS,HIP,SM-CONSTRAINED,NCMNTD,MTL/POLYMER, POROUS

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SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 54MM PRSTHSS,HIP,SM-CONSTRAINED,NCMNTD,MTL/POLYMER, POROUS Back to Search Results
Catalog Number 71335554
Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Failure of Implant (1924); Injury (2348); Joint Disorder (2373); Inadequate Osseointegration (2646); Subluxation (4525)
Event Date 12/18/2017
Event Type  Injury  
Event Description
It was reported that a revision surgery was performed on the left hip due to fail tha, with grossly loose and unstable femoral component. Since pre-operatively, tha was diagnosed failed and afterwards, intraoperatively, the stem was noticed loose and the cup was removed, it cannot be discarded the incidence of the removed components to the tha failure.
 
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Brand NameR3 3 HOLE ACET SHELL 54MM
Type of DevicePRSTHSS,HIP,SM-CONSTRAINED,NCMNTD,MTL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10166255
MDR Text Key195524646
Report Number1020279-2020-02488
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71335554
Device Lot Number16JM15600
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 Received06/16/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/28/2016
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: 06/18/2020 Patient Sequence Number: 1
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