MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS FEMORAL OXIN LT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74022125
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Subluxation (4525)
Date of Event	05/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka had been performed on (b)(6) 2018, the patient experienced knee pain and patellar subluxation on the left knee.In (b)(6) 2021, anterior pain and subluxation of patella still exists, and the patient will be offered a new revision surgery.This adverse event is going to be treated by another revision surgery on an unknown date.Current health status of patient is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, in journey ii bcs study it was reported that the subject received a journey knee in the contralateral (left) knee (b)(6) 2017 for primary osteoarthritis.Following the tka, subject is noted with left anterior knee pain and patellar subluxation.The provided x-rays were reviewed and show osteophytic changes on the patella but not active subluxation.However, without clinical/ medical records a thorough medical assessment cannot be performed.It is noted ¿will most likely be offered revision surgery¿ however, no revision has been reported.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 not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.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.
Event or Problem Description
It was reported that, after a tka had been performed on (b)(6) 2017, the patient experienced anterior knee pain and subluxation from (b)(6) 2018, which was unresolved at follow up on 14-jun-2021.The patient will most likely be offered revision surgery.
Additional Manufacturer Narrative
Event has been corrected.

• Brand Name: JRNY II BCS FEMORAL OXIN LT SZ 5
• 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: 12164356
• Report Number: 1020279-2021-05935
• Device Sequence Number: 11827087
• Product Code: JWH
• UDI-Device Identifier: 00885556170410
• UDI-Public: 00885556170410
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K11711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/04/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74022125
• Device Catalogue Number: 74022125
• Device Lot Number: 17BM01646
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 07/01/2021; 09/22/2021; 10/01/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 07/22/2021; 09/23/2021; 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JOURNEY TIBIA BASE NP LT SZ 4; JRNY II BCS XLPE ART ISRT SZ 3-4 LT 10MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 82