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

Model Number 74027211

Device Problem Incomplete or Inadequate Connection (4037)

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

Event Date 04/27/2021

Event Type  malfunction  

Event Description

It was reported that, during a tka, the jrny ii bcs xlpe art isrt sz 1-2 rt 9mm ((b)(4)) could not be inserted with the journey art isrt assm tool ((b)(4)).Instrument inside the patient.The procedure was completed without delay using both s+n back-up devices.Patient was not harmed.

Manufacturer Narrative

H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.The device was damaged likely from attempted insertion.A dimensional inspection was attempted, but the device was too damaged from the attempted insertion to obtain accurate measurements.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.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.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 BCS XLPE ART ISRT SZ 1-2 RT 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: 11821437
• MDR Text Key: 250505099
• Report Number: 1020279-2021-04263
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556178669
• UDI-Public: 00885556178669
• Combination Product (y/n): N
• PMA/PMN Number: K111711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

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
• Device Operator: Health Professional
• Device Model Number: 74027211
• Device Catalogue Number: 74027211
• Device Lot Number: 20JM02805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/13/2021
• Supplement Dates Manufacturer Received: 08/19/2021
• Supplement Dates FDA Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1