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

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event 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.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4-RT 12MM
• 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: 19052233
• MDR Text Key: 339606974
• Report Number: 1020279-2024-00683
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556179161
• UDI-Public: 00885556179161
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K111711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2024

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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1