MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR INS XLPE LAT 1-2 LT 8MM; PROSTH, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY

Model Number	74023820
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed 2 years after the primary procedure due to loosening and disassociation of the jrny ii xr ins xlpe lat 1-2 lt 8mm.

• Brand Name: JRNY II XR INS XLPE LAT 1-2 LT 8MM
• Common Device Name: PROSTH, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9974956
• Report Number: 1020279-2020-01317
• Device Sequence Number: 2176877
• Product Code: JWH
• UDI-Device Identifier: 00885556615553
• UDI-Public: 00885556615553
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152726
• 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): 12/08/2020

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: 74023820
• Device Catalogue Number: 74023820
• Device Lot Number: 17GM04691
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 12/08/2020
• 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: Hospitalization; Required Intervention