MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN JOURNEY BCS / JOURNEY II BCS KNEE TIB BASEPLATE; TRAY, SURGICAL, INSTRUMENT

Catalog Number UNKN01200309

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646); Joint Laxity (4526); Metal Related Pathology (4530)

Event Date 04/05/2022

Event Type  Injury  

Event Description

It was reported that, twelve (12) months after a robotically navigated tka surgery performed with a journey ii cr system, the patient experienced gross instability.Patient was wearing a brace for six (6) months.Pre-revision x-ray image shows the knee is misaligned.A revision surgery was performed around (b)(6) 2022 to explant the whole system.The femur is worn out and the insert is severely eroded.Patient's current health status is ignored.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

The device was not returned for evaluation and the reported event could not be confirmed.However, the clinical/medical investigation concluded that, the posted undated/unidentified x-ray image appears to show metallic debris in the surrounding tissue with possible radiolucencies around the tibial stem/baseplate, and that based on the imaging provided, the root cause of the reported event could not be definitively concluded; however, component loosening and/or a disassociated insert could not be ruled out as contributing factors, 3rd body wear, laxity in the knee are also options to the reported events as there was apparent undesired metallic wear on the femoral component, severe deformation of the insert which is seen with insert disassociation, and subsequent metal on metal articulation.The severity of the component deformation and metallic debris is likely directedly related to the length of time between the onset of gross instability and revision (reportedly 6 months).It is unknown if the patient sought medical intervention at symptom onset.The assessed patient impact was the gross instability, use of brace for 6 months, failed knee construct with adjacent metallic debris which was possibly due to a delay in medical/surgical intervention, and the subsequent revision with an anticipated post-operative recovery phase.No further patient impact or medical assessment can be rendered at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Potential causes could include but are not limited to friction, surgical technique used, user/procedural variance, joint tightness or lifetime of device.The contribution of the device to the reported incident could be corroborated as the x-ray show metallic debris in the surrounding tissue with possible radiolucencies around the tibial stem/baseplate and it was required a revision surgery to treat this event.Based on this investigation, the need for corrective action is not indicated.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.

• Brand Name: UNKNOWN JOURNEY BCS / JOURNEY II BCS KNEE TIB BASEPLATE
• Type of Device: TRAY, SURGICAL, INSTRUMENT
• 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: 14282349
• MDR Text Key: 290688528
• Report Number: 1020279-2022-02116
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01200309
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2022
• 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