MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY ARTICULAR INSERT BCS STANDARD 7-8 LEFT 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74023283
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Implant Pain (4561)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka was performed on an unspecified date, the patient experienced pain.This was solved by performing a revision surgery on (b)(6) 2023, in which the peg on the journey articular insert standard 7-8 left 11mm was found to be broken.Patient's current health status is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Additional Manufacturer Narrative
Results of investigation: the associated device was returned and evaluated.The visual inspection revealed the post fractured off.The broken post was returned.The visual also reveals scratches, burrs and discoloration on the insert.The device shows signs of wear.The knee insert post fracture may have been due to repeated posterior contact of the femoral cam on the post combined with excessive posterior to anterior shear force during activity.However, this could not be isolated as the root cause for this particular failure mode.Some additional factors that could have contributed to the reported event include patient anatomy, abnormal loading of limb and/or traumatic injury.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided for evaluation.The provided photo was reviewed and confirms the broken peg of the insert.However, the photo alone does not contribute to the clinical investigation of the root cause of the insert¿s breakage.There were no clinical factors found which would have contributed to the reported breakage.The patient's current condition is unknown and the patient impact beyond the revision surgery could not be determined.No further clinical assessment can be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The product was manufactured in adherence to all inspection procedures and quality controls required for ultra-high-molecular-weight polyethylene; therefore, there is no reason to suspect that the product failed to meet any specifications at the time of manufacture.A historical review for the alleged product concluded that the following previous action was implemented: due to a higher revision rate of the first generation journey bcs knee system identified in the national joint registry of england, wales and northern ireland (njrewni) and the australian orthopaedic association national joint replacement registry (aoanjrr), surgeons were appropriately notified 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.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, any future complaints will be monitored, and if necessary, additional corrective actions will be taken accordingly.A review of the instructions for use documents for knee systems revealed in warnings and precautions that the implant can break or become damaged as a result of strenuous activity or trauma.A review of the risk management file revealed this failure mode was previously identified.Based on this investigation, the need for additional 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: JOURNEY ARTICULAR INSERT BCS STANDARD 7-8 LEFT 11MM
• 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: 16657377
• Report Number: 1020279-2023-00745
• Device Sequence Number: 12581466
• Product Code: JWH
• UDI-Device Identifier: 03596010555366
• UDI-Public: 03596010555366
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

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 Expiration Date: 09/30/2016
• Device Model Number: 74023283
• Device Catalogue Number: 74023283
• Device Lot Number: 06JM00839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2006
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JRNY TIB BSPLTE LFT SZ7(PN:74022227,LN:08BM19267).
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male