MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY UNI TIBIAL BASE LM/RL SZ 3; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71422423

Device Problems Biocompatibility (2886); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Discomfort (2330); Joint Dislocation (2374); Inadequate Osseointegration (2646); Metal Related Pathology (4530)

Event Date 11/24/2022

Event Type  Injury  

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).

Event Description

It was reported that, after a cori assisted journey uka surgery was performed on the (b)(6) 2022, the patient presented to the practice on the (b)(6) 2022 due to a squeaking in the knee.A diagnosis followed and the x-ray findings were clear for revision, which was performed on the (b)(6) 2022.During the revision, severe metallosis was found and the inlay was not anchored in the tibial plateau; the tibia was loose.The revision was extensive with soft tissue removal.A legion system was implanted instead.The patient status is good.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the associated devices were returned and evaluated.A dimensional evaluation was performed on the tibial baseplate and the insert and revealed that the devices have signs of damage from use.The dimensional evaluation found that all applicable, critical features were within specification.The retrieved journey oxinium femoral sz 3, journey uni tibial baseplate lm/rl sz 3, and journey uni tibial insert lm/rl sz 3-4 8mm were examined using visual and macroscopic/microscopic methods.A lab analysis and visual examination showed damage of the articular surface of the femoral and near the lock regions of the tibial baseplate.Bone cement attachment was observed on the fixation surface of the femoral component.No bone cement attachment on backside of the tibial baseplate was observed.Macroscopic/microscopic examination showed scratches on the sides of the femoral and burnishing wear on the articular surface of the insert.Minimal damage was observed on the leading anterior edge lock detail on the insert.No additional unexpected visual features noted.No evidence of deviation in processing or material was found for the retrieved items.No definitive conclusions as to the cause of these issues can be determined.The clinical/medical investigation concluded that, based on the imaging provided, the collapse of articulating space along with the metallic debris deposition in a 2-month in-vivo uni-knee is consistent with the reported insert disassociation/dislocation, allowing metal-on-metal articulation between the femoral and tibial components, resulting in gouge in the femoral component along with deformation of the tibial baseplate and source of reported ¿squeaking¿.However, it cannot be concluded what role the finding of the tibial baseplate loosening played in the reported events.The patient impact included the reported ¿squeaking¿, ¿clear for revision¿ x-ray imaging, and intraoperative findings resulting in revision/conversion to total knee arthroplasty ¿extensive with soft tissue removal¿ with an anticipated post-op recovery phase.No further medical assessment can be rendered at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For jrny uni tibial base lm/rl sz 3 and journey uni tibinrt s3-4lm/rl8mm, a review of complaint history revealed similar events for the listed devices over the previous 12 months, but no similar events for the batches based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.For juni ox fb fem sz 3 lm rl, a review of complaint history for the part number over the previous 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed in warnings and precautions, that although rare, metal sensitivity or allergic reactions in patients following joint replacement have been reported.Besides, looseness of components have been identified in the possible adverse effects section 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.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to these products and event.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 irregular implant interaction, abnormal motion over time, alignment, size selected, inadequate integration between the cement and bone/implant and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should 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.Corrected data: b1 (type of event), b2 (outcomes updated), d9,h3 (device returned to manufacturer), h6 (health effect - clinical code, medical device problem code).

• Brand Name: JRNY UNI TIBIAL BASE LM/RL SZ 3
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 16016555
• MDR Text Key: 305826424
• Report Number: 1020279-2022-05003
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K102069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71422423
• Device Catalogue Number: 71422423
• Device Lot Number: 19KM09966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2019
• 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: 71422251/JOURNEY UNI TIBINRT S3-4LM/RL8MM; 71422343/JUNI OX FB FEM SZ 3 LM RL
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 93 KG