MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 1-2 RT 9MM; PRSTHSS,NEE, PTLLFMRTBL,SMI-CNSTRIND,CMNTD,PLYMR/MTL/PLYMR

Model Number	74027211
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during journey 2 left total knee case an incorrect insert (right j2 bcs) was implanted in the patient.The error was discovered after the patient had already been closed and taken to recovery.The surgeon was able to go back in later the same day as the case to replace the incorrect insert with the correct one.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is for a right knee.All of the product information on the device is correct and matches the part configuration.The device was manufactured in 2018.The medical investigation concluded that this complaint from the united states reports, during a journey ii left total knee case; an incorrect insert (right j2 bcs) was implanted in the patient.The error was discovered after the patient had already been closed and taken to recovery.The surgeon was able to go back in later the same day to replace the incorrect insert with the correct one.The device was returned and is indeed a right journey ii insert.Smith and nephew has not received adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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 documents revealed this failure mode was previously identified.The potential probable cause for this event is likely a user 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 1-2 RT 9MM
• Common Device Name: PRSTHSS,NEE, PTLLFMRTBL,SMI-CNSTRIND,CMNTD,PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9952949
• Report Number: 1020279-2020-01273
• Device Sequence Number: 19416660
• Product Code: JWH
• UDI-Device Identifier: 00885556178669
• UDI-Public: 00885556178669
• Combination Product (Y/N): N
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 74027211
• Device Catalogue Number: 74027211
• Device Lot Number: 18DM05127
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 07/08/2020
• 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