MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 7-8 LT 9; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 74023281

Device Problem Material Deformation (2976)

Patient Problems Failure of Implant (1924); Osteolysis (2377); Inadequate Osseointegration (2646)

Event Date 08/28/2023

Event Type  Injury  

Event Description

It was reported that, after a tka surgery performed on (b)(6) 2013, the patient underwent a revision surgery on (b)(6) 2023 due to loosening of the journey tibia base np lt sz 7.During surgery, it was noticed that the journ art ins bcs std 7-8 lt 9 was deformed but not yet broken, and that the journey tibia base np lt sz 7 was loose and sunken into tibia bone.Furthermore, there was macro evidence of black synovial staining, surgeon mentioned that the black synovial staining from the loose tibia was due to osteolysis, potentially caused by debri coming from the journey tibia base np lt sz 7.Both the journey tibia base np lt sz 7 and the journ art ins bcs std 7-8 lt 9 were replaced.Current health status of the patient is unknown.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

Section h3, h6: the devices were not returned for evaluation.However, the photographs were reviewed, and revealed that the post on the journey articular insert bcs std 7-8 lt 9mm is deformed.The clinical/medical investigation stated that the clinical root cause of the reported ¿deformed¿ articular bcs insert, and tibial baseplate ¿loose and sunken into the tibia bone¿, cannot be definitively concluded.However, based on the reported intraoperative findings, noting ¿the black synovial staining¿ was ¿due to osteolysis,¿ as reported by the surgeon.The patient impact beyond the reported loosening, osteolysis, and subsequent revision cannot be determined.The patient¿s current health status is unknown.Therefore, no further medical assessment can be rendered.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the devices did not reveal similar events for the listed devices.A review of the instructions for use documents for knee systems revealed that the implant can become damaged as a result of strenuous activity or trauma.Besides, looseness of components could occur as a result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.This has been identified as a warning and precaution and as a possible adverse effect.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of previous actions concluded that there is a higher than expected risk of revision surgery for the first generation of journey bcs systems.It was recommended to undertake a field safety corrective action to inform surgeons of the higher expected risk of revision, and ensure clear communication that the device should only be used for polyethylene exchange revision of journey bcs total knee constructs where the femoral component and tibial baseplate are well fixed.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, patient condition and/or bone quality.Based on this investigation, the need for corrective action is not indicated.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.

Event Description

It was reported that, after a tka surgery performed on (b)(6) 2013, the patient underwent a revision surgery on (b)(6) 2023 due to loosening of the journey tibia base np lt sz 7.During surgery, it was noticed that the journ art ins bcs std 7-8 lt 9 was deformed but not yet broken, and that the journey tibia base np lt sz 7 was loose and sunken into tibia bone.Furthermore, there was macro evidence of black synovial staining, surgeon mentioned that the black synovial staining from the loose tibia was due to osteolysis, potentially caused by debri coming from the journ art ins bcs std 7-8 lt 9.Both the journey tibia base np lt sz 7 and the journ art ins bcs std 7-8 lt 9 were replaced.Current health status of the patient is unknown.

• Brand Name: JOURN ART INS BCS STD 7-8 LT 9
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 17775334
• MDR Text Key: 323752683
• Report Number: 1020279-2023-01789
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010555342
• UDI-Public: 03596010555342
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K042515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2023

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 Expiration Date: 08/03/2020
• Device Catalogue Number: 74023281
• Device Lot Number: 10HM01331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 11/03/2023; 11/03/2023
• Supplement Dates FDA Received: 11/08/2023; 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2010
• 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
• Treatment: 74022227//10KM10918//JOURNEY TIBIA BASE NP LT SZ 7.
• Patient Outcome(s): Required Intervention