MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACC STD 265MM 11 CBL TRCH GRIP; CERCLAGE, FIXATION

Catalog Number 71340013

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 04/18/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent right total hip arthroplasty.The patient was doing well post-operative, but when it went to the md office for a follow-up visit, the x-ray reveals fracture in the plate.

• Brand Name: ACC STD 265MM 11 CBL TRCH GRIP
• Type of Device: CERCLAGE, FIXATION
• 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 ; 0447940038
• MDR Report Key: 10059972
• MDR Text Key: 191074741
• Report Number: 1020279-2020-01745
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71340013
• Device Lot Number: 18GSM0670
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 106