MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR INS XLPE MED 3-4 LT 8MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74023740
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Fibrosis (3167)
Date of Event	10/21/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a manipulation under anesthesia due to arthrofibrosis.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and no clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.However, a known common post-surgical complication, arthrofibrosis, was reportedly the contributing factor to the ae#1/mua.The documented ae#2/fall was reportedly resolved without treatment.The patient impact beyond the reported arthrofibrosis and subsequent mua could not be determined and the fall was reportedly resolved without intervention.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.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 XR INS XLPE MED 3-4 LT 8MM
• 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: 8746894
• Report Number: 1020279-2019-02583
• Device Sequence Number: 19254976
• Product Code: JWH
• UDI-Device Identifier: 00885556612835
• UDI-Public: 00885556612835
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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 Catalogue Number: 74023740
• Device Lot Number: 16BM09316
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 06/30/2019
• Supplement Report FDA Received Date: 10/30/2019
• 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: 51 YR