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

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).

• Brand Name: ECHELON HA STD 260 BOW S 12 L
• Type of Device: PROSTHESIS,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 Key: 12847152
• MDR Text Key: 282089751
• Report Number: 1020279-2021-08246
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K023302
• Number of Events Reported: 1
• 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 Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 12/16/2021
• Device Model Number: 71344412
• Device Catalogue Number: 71344412
• Device Lot Number: 11LM03195A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/19/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage