MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP RT SZ 5

Catalog Number	74021155
Health Effect - Clinical Code	Fibrosis (3167)
Date of Event	07/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented arthrofibrosis of total right knee arthroplasty.Event treatment included manipulation under anesthesia.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, no clinical relevant documents were provided to conduct a thorough medical assessment.The future impact to the patient beyond the mua cannot be determined.No medical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: JRNY II CR FEM OX NP RT SZ 5
• Common Device Name: JRNY II CR FEM OX NP RT SZ 5
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7837694
• Report Number: 1020279-2018-01676
• Device Sequence Number: 14037612
• Product Code: JWH
• UDI-Device Identifier: 00885556422847
• UDI-Public: 00885556422847
• 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: company representative,study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2018

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: 74021155
• Device Lot Number: 18CM03654
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 12/06/2018
• 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; Other; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 73