MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNEE-DUMMY IMPLANT; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number UNKNOWN/UNREADABLE

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 01/21/2020

Event Type  Injury  

Event Description

It was reported that revision surgery was performed for the first time due to the dissociation of the journey uni insert.

Manufacturer Narrative

Results of investigation: the device, used in treatment, was not returned for evaluation, and the reported event could not be confirmed.A clinical analysis indicated that this complaint from the united kingdom reports two revisions of a journey uni knee.The date of the primary surgery and the first revision are unknown.The first revision involved just the insert.The date of the second revision was january 21, 2020 and the tibial plate and the insert were exchanged.No clinical/medical documentation has been provided.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, surgical technique or size of device.Without the return of the actual product involved and no patient medical records, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: KNEE-DUMMY IMPLANT
• 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: 9735267
• MDR Text Key: 180706716
• Report Number: 1020279-2020-00652
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K061011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2024
• Device Model Number: UNKNOWN/UNREADABLE
• Device Catalogue Number: 71422265
• Device Lot Number: 14DM03683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1