MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II ISRT XLPE DD LT SZ 5-6 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 74025763

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 10/05/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a tka surgery, when opening the box of the jrny ii isrt xlpe dd lt sz 5-6 11mm device, it was found that the double sterile packages were open on same site.There was no damage on the box.The procedure was resumed, after a non-significant surgical delay, with a s+n back-up device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

H3, h6: the associated device packages were returned and evaluated.A visual inspection of the returned device reveals the sterile packages are open.A review made by the quality engineering team revealed that, based on the assessment of the device¿s sterile barrier system, the defect occurred in distribution and would not be related to a manufacturing issue.Additionally, the location where the pouches were ruptured is not the location where they are heat sealed in production.Visual inspections performed during production are set-up to detect any issues not only with the device but also with the sterile barrier system.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 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 part must be placed inside an inner pouch and then sealed.At this time, we have no reason to suspect that the packages failed to meet any specifications at the time of manufacture.Based on this investigation, the need for 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: JRNY II ISRT XLPE DD LT SZ 5-6 11MM
• 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: 18021342
• MDR Text Key: 326733154
• Report Number: 1020279-2023-02056
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556098516
• UDI-Public: 00885556098516
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113482
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 74025763
• Device Lot Number: 18EM10232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2018
• 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