MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE RT SZ 3-4 10MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74025632
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Fibrosis (3167)
Date of Event	04/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented arthrofibrosis which was resolved with an unspecified surgical procedure.
Additional Manufacturer Narrative
Additional information in event.
Event or Problem Description
It was reported that the patient presented arthrofibrosis with decreased range of motion and knee pain.Manipulation under anesthesia was performed on (b)(6) 2018 to resolve this issue.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and no relevant clinical medical information was provided to conduct a thorough medical assessment.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: JRNY II CR ISRT XLPE RT SZ 3-4 10MM
• 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: 8834717
• Report Number: 1020279-2019-02824
• Device Sequence Number: 2877135
• Product Code: JWH
• UDI-Device Identifier: 00885556422595
• UDI-Public: 00885556422595
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2019

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: 05/03/2024
• Device Catalogue Number: 74025632
• Device Lot Number: 14EM04195
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 07/03/2019; 07/03/2019
• Initial Report FDA Received Date: 07/28/2019
• Supplement Report FDA Received Date: 08/09/2019; 11/07/2019
• 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