MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN JOURNEY BCS / JOURNEY II BCS KNEE FEM COMP; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNKNOWN

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Osteolysis (2377); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2019

Event Type  Injury  

Event Description

On the literature article named "primary total knee arthroplasty performed using high-viscosity cement is associated with higher odds of revision for aseptic loosening", it was reported that, after journey ii system for primary tka had been implanted, 2 patients underwent a revision surgery due to aseptic loosening.No further information was provided.The outcome of this patients is unknown.

Manufacturer Narrative

The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the data provided was presented in the literature article named " primary total knee arthroplasty performed using high-viscosity cement is associated with higher odds of revision for aseptic loosening".Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of devices, and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN JOURNEY BCS / JOURNEY II BCS KNEE FEM COMP
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12118403
• MDR Text Key: 260055354
• Report Number: 1020279-2021-05690
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/05/2021
• Supplement Dates Manufacturer Received: 08/17/2021
• Supplement Dates FDA Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JOURNEY II BCS KNEE INSERT/UNK; JOURNEY II BCS KNEE TIB BASEPLATE/ UNK; UNKN JOURNEY BCS / JOURNEY II BCS KNEE PAT COMP/UN
• Patient Outcome(s): Hospitalization; Other; Required Intervention