MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DEUCE FEM OXZR SZ 4 LT; PROSTHE, KNEE PATELLOFEMOL, PARTIAL, SEMI-CONS, CEMEN, POLY/METAL/POLY

Catalog Number 71422204

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 11/07/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to fracture of the knee joint.

Manufacturer Narrative

It was reported that a revision surgery was performed due to fracture of the knee joint.The associated journey ii uni tibial insert, journey ii uni tibial baseplate and deuce femoral component, used in treatment, were not returned for evaluation.Therefore the product analysis could not be performed.As device details were not made available, the device history record review cannot be completed.There is no information that would suggest the devices failed to meet specifications.A relationship, if any, between the devices and the reported incident could not be corroborated.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Our investigation noted that the related base plate and the femoral component have been obsolete at this time.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.A review of instructions of use and risk assessment revealed the post-operative issue is previously identified in the possible adverse events.Possible causes could include but not limited to patient medical history, age of patient or traumatic injury.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: DEUCE FEM OXZR SZ 4 LT
• Type of Device: PROSTHE, KNEE PATELLOFEMOL, PARTIAL, SEMI-CONS, CEMEN, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9391737
• MDR Text Key: 168439745
• Report Number: 1020279-2019-04203
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• PMA/PMN Number: K052265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

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: 71422204
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 11/29/2019
• Supplement Dates Manufacturer Received: 11/08/2019
• Supplement Dates FDA Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention