MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS CNSTRD ART ISRT 3-4 LT 21M; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74029248
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after tka it was noticed that a journey insert was implanted in a legion tibial baseplate.No delay or injury reported.A revision surgery had to be performed to remove and re-implant a legion poly.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, reportedly after tka it was noticed that a journey insert was implanted in a legion tibial baseplate.It has not been communicated if a intervention will take place to correct the event.A review of the details provided in this case indicates a potential procedural related event has occurred.No radiographs have been provided for inclusion in the medical assessment.The patient's status post operatively is unknown.No further medical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: JRNY II BCS CNSTRD ART ISRT 3-4 LT 21M
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8547079
• Report Number: 1020279-2019-01656
• Device Sequence Number: 10854658
• Product Code: JWH
• UDI-Device Identifier: 00885556176368
• UDI-Public: 00885556176368
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2019

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 Expiration Date: 06/05/2023
• Device Catalogue Number: 74029248
• Device Lot Number: 13FM05260
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 10/19/2019
• 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: Hospitalization; Required Intervention