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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECHELON HA STD 260 BOW S 12 L PROSTHESIS,HIP,SEMICONSTRAINED,UNCEMENTED,METALPOLYMER,CALICUMPHOSPHATE

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SMITH & NEPHEW, INC. ECHELON HA STD 260 BOW S 12 L PROSTHESIS,HIP,SEMICONSTRAINED,UNCEMENTED,METALPOLYMER,CALICUMPHOSPHATE Back to Search Results
Model Number 71344412
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Failure of Implant (1924)
Event Date 11/01/2021
Event Type  Injury  
Event Description
It was reported that, after a tha was performed on an unspecified date, the patient experienced a joint capsule infection and the echelon ha std 260 bow s 12 l was broken. This adverse event was solved by a revision surgery on (b)(6) 2021, in which the ref no hole shell sz 52mm, echelon ha std 260 bow s 12 l, oxinium fem hd 12/14 32mm +8 and an unknown reflection liner were explanted. Current health status of patient is unknown.
 
Manufacturer Narrative
Internal complaint reference (b)(4).
 
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Brand NameECHELON HA STD 260 BOW S 12 L
Type of DevicePROSTHESIS,HIP,SEMICONSTRAINED,UNCEMENTED,METALPOLYMER,CALICUMPHOSPHATE
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 Key12847152
MDR Text Key282089751
Report Number1020279-2021-08246
Device Sequence Number1
Product Code MEH
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 Other,Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/16/2021
Device Model Number71344412
Device Catalogue Number71344412
Device Lot Number11LM03195A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/02/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/19/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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