MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP RT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74021154
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a tka surgery, it was noticed that the packaging inside the box was unsterile, as the lid on the inner plastic packaging of a jrny ii cr fem ox np rt sz 4 was missing.Furthermore, in the picture provided, it appears that the tray is missing a seal transfer on the corner.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
Section h3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals the lid on the inner plastic packaging is missing.However, a review made by the quality engineering team revealed that the purpose of the double sterile package is to keep the product sterile even if it breaks out of the inner tray and outer tray lid is still intact.In this case, the inner lid was missing and the outer lid has a complete seal which makes the product sterile.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 inspection procedure, the inner and outer lid must be checked for damage.Additionally, the packaging sequence, indicates that the inner tray lid must be snapped into and securely sealed to the inner tray.At this time, we do have reason to suspect that the product failed to meet specifications at the time of manufacture.Factors that could contribute to the reported event include, mishandling and/or manufacturing process errors.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 CR FEM OX NP RT SZ 4
• 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: 18278539
• Report Number: 1020279-2023-02411
• Device Sequence Number: 6667338
• Product Code: JWH
• UDI-Device Identifier: 00885556422854
• UDI-Public: 00885556422854
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2024

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: 74021154
• Device Lot Number: 23EM04628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2023
• 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