MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4 LT 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIND, CEMENTD, POLY/METAL/POLY

Model Number	74027242
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a tka procedure the journey ii bcs xlpe art isrt size 3-4 left 10mm did not seat fully onto the baseplate.The inserter connection pocket which is located on the anterior of insert, was damaged because the insert was tried to be set onto the baseplate repeatedly.Finally the back-up, different size, was utilized and completed the surgery.Surgery was delayed for no longer than 30 min.
Additional Manufacturer Narrative
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 has signs of damage from attempted use.The device was manufactured in 2020.The clinical / medical investigation concluded that, this case reports that insert did not seat fully onto the baseplate and became damaged after repeated attempts.Per email communication, there was no harm to the patient, and the procedure was completed using a backup of a different size.There was a delay of less than 30-minutes.Since no patient harm is alleged, no further clinical assessment is warranted.A dimensional inspection was attempted but the device was too damaged from the attempted insertion to obtain accurate measurements.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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 documents revealed this failure mode was previously identified.Some potential probable causes for this event could include a fit/sizing issue or a procedural error.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.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4 LT 10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIND, CEMENTD, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10760135
• Report Number: 1020279-2020-05948
• Device Sequence Number: 1191839
• Product Code: JWH
• UDI-Device Identifier: 00885556177662
• UDI-Public: 00885556177662
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2021

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
• Operator of Device: Health Professional
• Device Model Number: 74027242
• Device Catalogue Number: 74027242
• Device Lot Number: 20AM17757
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 01/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention