MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN JOURNEY UNI KNEE TIB BASEPLATE; KNEE ARTHROPLASTY IMPLANTATION SYSTEM

Catalog Number UNKNOWN

Device Problem Loss of Osseointegration (2408)

Patient Problem Inadequate Osseointegration (2646)

Event Date 10/18/2019

Event Type  Injury  

Event Description

It was reported that after a left tka performed on (b)(6) 2012 due to osteoarthritis, the patient experienced a aseptic loosening of the tibial component.This was addressed via revision surgery on (b)(6) 2019 were all components where exchange to competitor´s implants.This information was provided by the national joint registry of (b)(6), as part of a retrospective data collection of patients who underwent a revision surgery of journey uni prothesis.As such, no further information will be available.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

H3, h6: given the nature of the alleged incident, the device, could not be returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a left revision was performed approximately 7 years post uka due to aseptic loosening of the tibial component.As of the date of this medical investigation, the requested clinical documentation has not been received as the information was provided by the national joint registry of the united kingdom as part of a retrospective data collection, and reportedly, no further information will be available.Without the requested medical documentation, possible clinical factors which could have contributed to the reported event could not be definitively concluded.The patient impact beyond that which was reported could not be determined.At this time, we have no reason to suspect that the product 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, osteolysis and/or traumatic injury.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device 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.Internal complaint reference number: (b)(4).

• Brand Name: UNKN JOURNEY UNI KNEE TIB BASEPLATE
• Type of Device: KNEE ARTHROPLASTY IMPLANTATION SYSTEM
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15358588
• MDR Text Key: 299279864
• Report Number: 1020279-2022-03958
• Device Sequence Number: 1
• Product Code: OOG
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2022
• 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): Required Intervention
• Patient Sex: Female