MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74027234
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during tka surgery, as the scrub team were opening the sterile jrny ii bcs xlpe art isrt sz 3-4-rt 12mm, the outer box was sealed correctly and wrapped in cellophane, the inner box however, was not glued down correctly, on further inspection the second inner box was also not glued.The procedure was resumed, after a non-significant delay, with a s+n back-up device.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the associated packaging was returned and evaluated.The visual inspection revealed that there is no glue residue on the second inner box.This inspection was conducted by naked eye.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.However, a review made by the quality engineering team revealed that the vacuum packaging process is the most likely cause of the failure identified.A review of complaint history for the part number over the past 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 risk management file 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 product and event.According to the packaging sequence, the inner tray lid should be fully sealed to the inner tray and the outer tray lid to outer tray.At this time, we do have evidence to conclude that the product failed to meet specifications at the time of manufacture.Based on this investigation, the need for corrective action is 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 BCS XLPE ART ISRT SZ 3-4-RT 12MM
• 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: 19052233
• Report Number: 1020279-2024-00683
• Device Sequence Number: 15201667
• Product Code: JWH
• UDI-Device Identifier: 00885556179161
• UDI-Public: 00885556179161
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 74027234
• Device Lot Number: 23DM05720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2023
• 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
• Patient Sex: Unknown