MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 RT 9; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74023251
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a tka surgery performed on 2007, the post of the journ art ins bcs std 5-6 rt 9 broke off.This was treated with a revision surgery performed on (b)(6) 2024.Current health status of the patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
The device was not returned for evaluation.However, the photographs were reviewed, and revealed that a section of the post fractured off of the journ art ins bcs std 5-6 rt 9.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed part number over the previous 12 months, but no similar events for the batch based on the historical data, 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, and has a finite expected service life and may need to be replaced in the future.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.According to the inspection procedure, part configuration must be compared to print.Additionally, the product shall be inspected for any damaged areas.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 injury.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: JOURN ART INS BCS STD 5-6 RT 9
• 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: 21026805
• Report Number: 1020279-2024-02757
• Device Sequence Number: 9052213
• Product Code: JWH
• UDI-Device Identifier: 03596010555137
• UDI-Public: 3596010555137
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• 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): 01/23/2025

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: 74023251
• Device Lot Number: 07BM11280
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown