MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 LT11; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74023263
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032)
Date of Event	03/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that, after a left tka surgery had been performed on (b)(6) 2010, the patient experienced severe left knee pain fourteen years post-operative.On (b)(6) 2024, the patient experienced a sharp pain in her left knee in the middle of the night and could not walk very well.The pain got a little better with more moving, and was worse sitting than standing up.Patient took ibuprofen, but it did not help.On (b)(6) 2024, the patient woke up from a severe pain after moving their legs while sleeping, and she was not able to straighten her left leg as knee was locked in a painful angle.The patient was admitted into the emergency room and a revision surgery was performed on (b)(6) 2024, where the post of a journey art insert bcs std 5-6 lt 11mm was noticed to be broken.This implant was replaced with a new, unknown insert.Patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6: the device was received for evaluation at the manufacturing site, but a physical product evaluation was not possible.The clinical/medical investigation stated that the images provided show the implants in position but no radiolucency¿s or abnormalities to conclude a root cause.Since the patient¿s current health status was not provided, no further medical assessment can be rendered at this time.The patient impact beyond the reported revision could not be determined.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed that the implant can break or become damaged as a result of strenuous activity or trauma.This has been identified as a warning and precaution.A review of the risk management file revealed this failure mode was previously identified.A review of previous actions concluded that there is a higher than expected risk of revision surgery for the first generation of journey bcs systems.It was recommended to undertake a field safety corrective action to inform surgeons of the higher expected risk of revision, and ensure clear communication that the device should only be used for polyethylene exchange revision of journey bcs total knee constructs where the femoral component and tibial baseplate are well fixed.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 patient anatomy, abnormal loading of limb, excessive forces 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.

• Brand Name: JOURN ART INS BCS STD 5-6 LT11
• Common Device Name: 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: 19130867
• Report Number: 1020279-2024-00770
• Device Sequence Number: 15167044
• Product Code: JWH
• UDI-Device Identifier: 03596010555229
• UDI-Public: 03596010555229
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 74023263
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 08/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0003-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEPUY HIGH VISCOSITY CEMENT; UNKNOWN JRNY BCS 35MM PATELLAR COMP; UNKNOWN JRNY BCS OX FEM COMP SIZE 6; UNKNOWN JRNY BCS TI TIB COMP SIZE 5
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 100 KG