MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP LT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Catalog Number	74021164
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/02/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient presented arthrofibrosis on the left knee.Adverse event was treated with manipulation under anesthesia.Event was resolved.
Additional Manufacturer Narrative
The device, used in treatment was not returned for evaluation.Without the actual product, product evaluation could not be performed and complaint could not be confirmed.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history for the listed part revealed no prior complaints.From clinical/medical investigation, a review of the case report forms did not provide any insight into the root cause of the reported arthrofibrosis.No x-ray images or information on the patient compliance with post-operative instructions were provided.Per the crf the reported issue has been documented as resolved.Since no further harm is anticipated, no further clinical/medical assessment is warranted at this time.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.Credit will not be issued for the device.

• Brand Name: JRNY II CR FEM OX NP LT SZ 4
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10063705
• Report Number: 1020279-2020-01764
• Device Sequence Number: 17022679
• Product Code: JWH
• UDI-Device Identifier: 00885556422793
• UDI-Public: 885556422793
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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 Catalogue Number: 74021164
• Device Lot Number: 17KM17973
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 01/25/2021
• 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
• Patient Weight: 68