MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 LT13; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74023264
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after primary tka surgery, patient presented as a little unstable, and revision surgery was performed to remove the journey articular insert bcs standard 5-6 left 13mm.The poly was replaced with a 15mm constrained poly.The patient was stable on table.Additional details have not been provided at this time.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this case reports a revision/insert exchange was performed due to instability.To date, the requested surgical records and x-rays have not been provided.Without sufficient supporting medical evidence a clinical assessment cannot be rendered at this time.Should additional clinically relevant documentation become available, the clinical/medical task may be re-opened.A review of complaint history did not reveal additional complaints for the listed device.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to fit/sizing issue, lifetime of device or patient condition.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JOURN ART INS BCS STD 5-6 LT13
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11568074
• Report Number: 1020279-2021-02360
• Device Sequence Number: 17009371
• Product Code: JWH
• UDI-Device Identifier: 03596010555236
• UDI-Public: 03596010555236
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

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: 74023264
• Device Catalogue Number: 74023264
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 08/24/2021
• 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; Other; Required Intervention