MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS CNSTRD ART ISRT 5-6 LT 11M; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74029263
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Arthralgia (2355)
Date of Event	04/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery had been performed on (b)(6) 2021, the patient experienced pain and swelling from infection.A revision surgery was performed on (b)(6) 2021 to treat this adverse event.The jrny ii bcs cnstrd art isrt 5-6 lt 11m was explanted and a washout procedure performed.The device explanted was replaced with a jrny ii bcs cnstrd art isrt 5-6 lt 13m.The patient outcome is unknown.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per email correspondence, the requested surgical records and x-rays are unavailable.Without the requested documentation, the clinical root cause of the post-op infection cannot be concluded.The patient impact beyond the wash-out and revision cannot be determined.No further medical assessment can be rendered at this time.Should additional clinically relevant documentation become available the medical investigation task may be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.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 are not limited to contamination, patient reaction, and post-operative healing issue.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: JRNY II BCS CNSTRD ART ISRT 5-6 LT 11M
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11894199
• Report Number: 1020279-2021-04708
• Device Sequence Number: 13806337
• Product Code: JWH
• UDI-Device Identifier: 00885556176511
• UDI-Public: 00885556176511
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K140555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/23/2023
• Device Model Number: 74029263
• Device Catalogue Number: 74029263
• Device Lot Number: 13FM17059
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 08/27/2021
• 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 Age: 63 YR
• Patient Weight: 98