MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II ISRT TRL DEEP DISHED LT 7-8 11M; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/

Model Number	74035783
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	02/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference number: case(b)(4).
Event or Problem Description
It was reported that, after a knee surgery had been performed, the patient experienced an unspecified adverse event that required a revision surgery to exchange the dish in the cr knee.The patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The affected complaint device, used in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed.There is no information that would suggest the device failed to meet specifications.A review of complaint history for the listed part revealed no prior complaints.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.According to clinical/medical investigation, this case reports a revision/poly exchange surgery was performed for an unknown adverse event.To date, he requested surgical reports and x-rays have not been provided.Therefore, the patient impact beyond the revision cannot be determined.Due to the limited information provided, no further clinical assessment can be rendered at this time.Should additional clinically relevant documentation become available, the clinical/medical task may be re-opened.The potential probable causes for this event could include but not limited to a user or procedural error.Based on this investigation, the need for corrective action is not indicated.A review of risk management files and the instructions for use found that the probable cause failures were documented appropriately.The potential probable causes for this event could include but not limited to a patient condition, user or procedural error.A review of risk management files and the instructions for use found that the probable reported failures were documented appropriately.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JRNY II ISRT TRL DEEP DISHED LT 7-8 11M
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11479557
• Report Number: 1020279-2021-02146
• Device Sequence Number: 3625305
• Product Code: JWH
• UDI-Device Identifier: 00885556534359
• UDI-Public: 00885556534359
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

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 Model Number: 74035783
• Device Catalogue Number: 74035783
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 05/04/2021
• 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