MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR INS XLPE MED 3-4 LT 8MM; PRTHSIS,KNEE,PATLLOFMORTIBL,SMI-CNSTRND,CMNTD,PLYMR/MTAL/PLYMR

Model Number	74023740
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to stiffness and wrong rom.Surgeon does not blame the implants.

• Brand Name: JRNY II XR INS XLPE MED 3-4 LT 8MM
• Common Device Name: PRTHSIS,KNEE,PATLLOFMORTIBL,SMI-CNSTRND,CMNTD,PLYMR/MTAL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9774080
• Report Number: 1020279-2020-00750
• Device Sequence Number: 19224466
• Product Code: JWH
• UDI-Device Identifier: 00885556612835
• UDI-Public: 00885556612835
• Combination Product (Y/N): N
• PMA/510(K) Number: K152726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

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: 74023740
• Device Catalogue Number: 74023740
• Device Lot Number: 18HM13141
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 01/19/2021
• 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