MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE LT SZ 1-2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 74025621

Device Problems Degraded (1153); Material Disintegration (1177)

Patient Problems Calcium Deposits/Calcification (1758); Fall (1848); Deformity/ Disfigurement (2360); Metal Related Pathology (4530); Implant Pain (4561)

Event Date 11/28/2023

Event Type  Injury  

Event Description

It was reported that, after a tka surgery using a journey system, had been performed on (b)(6) 2019, the patient experienced a fall and developed knee pain.On subsequent follow-up, x-ray image showed calcification and suspected deformation of the medial condyle of the femoral component or wear of the insert.Revision surgery is scheduled.Current health status of patient is unknown.

Manufacturer Narrative

Internal complaint number: (b)(4).

Event Description

It was reported that, after a tka surgery using a journey system, had been performed on (b)(6) 2019, the patient experienced a fall and developed knee pain.On subsequent follow-up, x-ray image showed calcification and suspected deformation of the medial condyle of the femoral component or wear of the insert.Revision surgery is scheduled for (b)(6) 2024.Current health status of patient is unknown.

Manufacturer Narrative

B5: describe event or problem and h6: medical device problem code.Section h3, h6: given the nature of the alleged incident, the devices could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that reportedly, the fall was the contributing factor to the reported event; however, the revision procedure is pending/scheduled as of the date of this medical investigation and further assessment is pending receipt of additional medical records.No clinical factors have been identified which would have contributed to the reported event.The patient impact included the fall, subsequent knee pain, the appearance of metallic debris throughout the left knee joint which was reported as ¿calcification and suspected deformation of the medial condyle of the femoral component or wear of the insert¿, and the scheduled revision total knee arthroplasty for (b)(6) 2024.Further patient impact could not be determined at this time but natural wear of the total knee arthroplasty components is not supported.The devices' batch numbers were not provided, thus, an evaluation of the manufacturing records could not be performed.For the insert, a review of complaint history of the previous 12 months revealed a similar event for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.For the femoral component, a review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed in possible adverse effects that wear of the polyethylene articulating surfaces of knee replacement components has been reported following total knee replacement.Higher rates of wear may be initiated by particles of cement, metal, or other debris which can cause abrasion of the articulating surfaces.Higher rates of wear may shorten the useful life of the prosthesis, and lead to early revision surgery to replace the worn prosthetic components.Additionally, revealed that periarticular calcification or ossification, with or without impediment to joint mobility has been identified as a possible adverse effect.Lastly, revealed in warnings and precautions that the patient should be warned that the device does not replace normal healthy bone, and that the implant can break or become damaged as a result of strenuous activity or trauma, and has a finite expected service life and may need to be replaced in the future.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 this products and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include friction or joint tightness.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.

• Brand Name: JRNY II CR ISRT XLPE LT SZ 1-2 9MM
• 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: 18389808
• MDR Text Key: 331292422
• Report Number: 1020279-2023-02575
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556422670
• UDI-Public: 00885556422670
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 74025621
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 68 KG