MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP RT SZ 6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74022216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extravasation (1842); Pain (1994); Injury (2348)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was discussed to be performed due to patient presenting pain.Surgeon explanted the femur, tibia and insert with minimal bone loss.He used j&j revision implants.The patient received the primary surgery on (b)(6) 2019.The patella was left.The surgeon could not clinically find any problems for patient¿s complaint of pain, except for a probable limited posterior slope on tibia.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device has cement stuck to the inner surface and has signs of damage from extraction.The clinical medical evaluation concluded that, based on the documentation provided, the root cause of the reported pain and subsequent revision cannot be confirmed but likely mal-positioning of the primary implants as stated by the revising surgeon.The patient impact beyond the reported pain, noted hemarthrosis, and the revision procedure could not be determined.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.The potential probable cause for this event is likely device mal-positioning.Based on this investigation, the need for corrective action is not indicated.Should 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.

• Brand Name: JOURNEY TIBIA BASE NP RT SZ 6
• 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: 10522694
• Report Number: 1020279-2020-04554
• Device Sequence Number: 3182874
• Product Code: JWH
• UDI-Device Identifier: 03596010554307
• UDI-Public: 03596010554307
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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: 74022216
• Device Catalogue Number: 74022216
• Device Lot Number: 18MM00754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 07/29/2021
• 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: 68 YR
• Patient Weight: 78