MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP LT SZ 7; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,PLYMR/METAL/PLYMR

Model Number	74021167
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient presented left knee arthrofibrosis.Adverse event was treated with manipulation under anesthesia.Event was resolved.

• Brand Name: JRNY II CR FEM OX NP LT SZ 7
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,PLYMR/METAL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 10013670
• Report Number: 1020279-2020-01408
• Device Sequence Number: 2952911
• Product Code: JWH
• UDI-Device Identifier: 00885556422762
• UDI-Public: 00885556422762
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

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: 74021167
• Device Catalogue Number: 74021167
• Device Lot Number: 17LM18673
• Initial Date Received by Manufacturer: 04/06/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 12/11/2020
• 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
• Patient Weight: 108