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

Catalog Number UNKNOWN

Device Problems Biocompatibility (2886); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Infiltration into Tissue (1931); Joint Laxity (4526)

Event Date 03/03/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after total knee arthroplasty was performed in 2010, the patient experienced wear on the poly and a potential cell attachment to the femoral component.It was determined that there was corrosion and external rotation of the femoral component, as well as severe wear and oxidation on the poly from engagement to the femoral component, that lead to joint instability.The poly was also confirmed to present localized delamination on medial condyle, anteriorly, and cracks anteriorly.In addition, the tibial baseplate was observed to be worn.Analysis of metal ion levels of periprosthetic tissue demonstrated high levels of ti (110 ppm), al (14 ppm), and v (5.3 ppm), which are trace of elements from the tibia baseplate (tialv alloy), confirming the generation of debris that resulted in tissue staining.This adverse event was treated with a revision surgery on (b)(6) 2022.Patient's current health status is unknown.

Manufacturer Narrative

H10: the device was not returned for evaluation, but the pictures were reviewed, and they confirm that the device shows wear and scratching on its surface.Metal ion analysis demonstrated ¿high levels¿ of trace elements from the tibial baseplate (tialv alloy) confirming generation of debris that resulted in tissue staining.The clinical/medical investigation concluded that, per the citra implant retrieval report, the revision was due to ¿wear and joint instability in a tka with external rotation of the femoral component, gross pe wear including of the ps post, and severe backside wear¿, also noting ¿tissue staining, ps post and condyle delamination, likely 3rd body wear and unexpected finding of gross backside wear of both the pe and the tibial component¿.Although likely multi-factorial, based on the limited information provided, further root cause analysis cannot be performed.The patient impact beyond that which was reported, including the revision, cannot be determined.No further medical 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, joint tightness, abnormal loadings on the implant or lifetime of device.The contribution of the device to the reported event could be corroborated since a revision surgery was required to exchange the damaged implant.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.Internal complaint reference number: (b)(4).

• Brand Name: JOURNEY BCS / JOURNEY II BCS KNEE TIB BASEPLATE
• Type of Device: ORTHOPEDIC STEREOTAXIC 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: 14691088
• MDR Text Key: 294014833
• Report Number: 1020279-2022-02999
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/24/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2022
• Initial Date FDA Received: 06/14/2022
• Supplement Dates Manufacturer Received: 06/23/2022
• Supplement Dates FDA Received: 06/24/2022
• 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: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female