MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE RT SZ 1-2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 74025611

Device Problems Unsealed Device Packaging (1444); Incomplete or Missing Packaging (2312)

Patient Problems Failure of Implant (1924); Injury (2348); No Information (3190); Insufficient Information (4580)

Event Date 06/29/2020

Event Type  Injury  

Event Description

It was reported that, during tka surgery, when the box was opened it could be clearly seen that the journey ii cr insert xlpe right size 1-2 9 mm implant was not packaged.The surgeon had to use an implant of different size from the originally planned.The procedure was finished with a surgical delay of less than 30 minutes with no further injury to the patient.

Event Description

It was reported that during tka surgery, upon opening implant box, the journey ii cr insert xlpe right size 1-2 9mm fell from the box, this occurred because the sterile wrap was undone.A second journey ii cr insert xlpe right size 1-2 9mm was available and after opened the implant box, and upon looking in, it could clearly see that the implant was not packaged.The surgeon had to use an implant of different size from the originally planned.The procedure was finished with a surgicla delay of less than 30 minutes with no injury to patient.

Manufacturer Narrative

D3,g3,h2, h3 and h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device was returned without its packaging.A review of the provided pictures appeared to show the device in its opened original box with the device not sealed in the sterile pouch.The pouch appeared to have a breached seal.The device shows no sign of use.The clinical medical investigation concluded that, based on the information provided, the root cause of the reported event could not be definitively concluded, although shipping/handling/storage variances outside of s+n control and/or inadequate packaging materials could also contribute to such reported events.Possible patient impact due to the implantation of the unplanned, thicker poly could be subsequent joint tightness, reduced rom, and discomfort; however, none could be confirmed based on the limited information provided and the report of ¿no injury to patient¿.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documentation revealed this failure mode was previously identified.Some potential probable causes for this event could include improper storage or rough handling.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.B5: update description g1: update contact name and address.

• Brand Name: JRNY II CR ISRT XLPE RT SZ 1-2 9MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10284023
• MDR Text Key: 199110378
• Report Number: 1020279-2020-03267
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556422748
• UDI-Public: 00885556422748
• Combination Product (y/n): N
• PMA/PMN Number: K121443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Model Number: 74025611
• Device Catalogue Number: 74025611
• Device Lot Number: 13MM01438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention