MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOUR AR ISR TR BCS STD7-8 RT10; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number 74033272

Device Problem Insufficient Information (3190)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Date 08/13/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to instability.

Manufacturer Narrative

The associated complaint device was not returned.The clinical medical team concluded, no clinical relevant documents were provided to conduct a thorough medical assessment.No medical assessment is warranted at this time.This complaint will be re-evaluated if more information becomes available.Without the actual products involved, our investigation cannot proceed.Reviewing the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: JOUR AR ISR TR BCS STD7-8 RT10
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0110447940
• MDR Report Key: 7856162
• MDR Text Key: 119552799
• Report Number: 1020279-2018-01750
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 03596010558718
• UDI-Public: 03596010558718
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74033272
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Other; Required Intervention