MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JUNI OX FB FEM SZ 5 RM LL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71422355

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 05/08/2018

Event Type  Injury  

Event Description

It was reported that five week after primary, prosthesis was explanted.Details for revision surgery unspecified.An alternative prosthesis was implanted.

Manufacturer Narrative

The affected journey uni tibial insert, oxinium component and journey uni tibial baseplate were not returned for evaluation.Therefore a thorough product analysis could not be performed.After repeated requests, smith and nephew has been unable to obtain device details and the reason for revision.As device details were not made available, device history record review cannot be completed.Complaint history review could not be performed with any accuracy due to lack of product information.Smith and nephew has an outstanding request with the reporter for information.Without the return of the actual product involved and no batch information available, our investigation of this report is inconclusive.Our clinical analysis noted no clinical relevant documents were provided to conduct a thorough medical assessment.No medical assessment is warranted at this time.The impact to the patient beyond the revision cannot be determined at this time.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.

• Brand Name: JUNI OX FB FEM SZ 5 RM LL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8364032
• MDR Text Key: 136934727
• Report Number: 1020279-2019-00755
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010627414
• UDI-Public: 03596010627414
• Combination Product (y/n): N
• PMA/PMN Number: K073175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71422355
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/22/2019
• Supplement Dates Manufacturer Received: 01/30/2019
• Supplement Dates FDA Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention