MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4 LT 15MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER

Catalog Number	74027246
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); Joint Swelling (2356)
Date of Event	11/02/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to instability.Patient was revised in full with legion revision.This is the fourth revision surgery this patient had went trough.
Additional Manufacturer Narrative
The associated journey ii bcs xlpe articular insert was not returned for evaluation.A clinical evaluation noted that no clinical documents are available at this time.Therefore, a thorough clinical assessment of the reported issue cannot be rendered.Our investigation including a review of the manufacturing records for the listed part with the listed batch 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 failure mode with the same batch number.There is no information that would suggest the implanted device failed to meet specifications.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4 LT 15MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8106873
• Report Number: 1020279-2018-02604
• Device Sequence Number: 1998025
• Product Code: JWH
• UDI-Device Identifier: 00885556177860
• UDI-Public: 00885556177860
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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: 07/27/2023
• Device Catalogue Number: 74027246
• Device Lot Number: 13GM18970
• Initial Date Received by Manufacturer: 11/04/2018
• Supplement Date Received by Manufacturer: 11/04/2018
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 04/19/2019
• 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
• Patient Age: 68 YR