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

Catalog Number UNKNOWN

Device Problem Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Infiltration into Tissue (1931); Osteolysis (2377); Hyperextension (4523); Joint Laxity (4526)

Event Date 06/25/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a total knee arthroplasty was performed in 2010, the patient experienced wear on the poly and cell attachment to the femoral component.It was determined that there was a femoral component external rotation and a subsequent fracture of the poly.The tibial component was confirmed to present superior surface and interfacial wear.This adverse event was treated with a revision surgery on (b)(6)2021.Upon removal tissue staining, implant debris, bone resorption, and well fixed cement were observed.Patient's current health status is unknown.

Manufacturer Narrative

Section h3, h6: the device was not returned for evaluation, but the photos provided confirm that the surface shows wear on the device.The clinical/medical investigation concluded that, per the citra implant retrieval report, the revision was due to symptomatic ¿wear and joint instability in a tka with external rotation of the femoral component, gross pe wear including of the ps post, ps fracture and substantial backside wear¿ also noting ¿hyperextension, tissue staining, implant debris, bone resorption and cement/tibial component interfacial wear¿.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.

• Brand Name: JOURNEY BCS / JOURNEY II BCS KNEE TIB BASEPLATE
• Type of Device: ORTHOPEDIC MANUAL 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: 14691092
• MDR Text Key: 294015057
• Report Number: 1020279-2022-03001
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• 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

• Date FDA Received: 06/14/2022
• 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?: Yes
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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