MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 74027232

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference (b)(4).

Event Description

It was reported that, during a tka surgery, the sterile box of a jrny ii bcs xlpe art isrt sz 3-4-rt 10mm was noticed to be not fully sealed.Therefore the sterility of the implant was questionable, 75% of the package was open and 25% of the package was sealed.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

H10: a re-assessment performed by the manufacturer identified that this event should be re-evaluated for mdr reporting.The provided pictures confirm that the inner packaging tray was unsealed; however, the polybag that contains the implant was delivered fully sealed.Based on this evidence, it was determined that the issue does not meet the threshold for reporting.As there was no sterility breach, this case is a non-reportable event.If further details are provided, our files will be updated accordingly, and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4-RT 10MM
• 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: 18383073
• MDR Text Key: 331206294
• Report Number: 1020279-2023-02555
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556179062
• UDI-Public: 00885556179062
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 74027232
• Device Lot Number: 23HM05197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Date Device Manufactured: 08/09/2023
• 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