MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS FEMORAL OXIN RT SZ 3; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74027231
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Journey ii bcs europe study (r11009-7-8); subject: 50-011; ae#03: it was reported that the patient had an anterior knee pain due to maltracking of patella.There is a lateralization and low patellar tilt on 5 year x-ray.There was no medical intervention performed for the patient adverse event.
Event or Problem Description
It was reported that the patient had an anterior knee pain due to mal-tracking of patella.There was a lateralization and low patellar tilt showed on a 5 year x-ray.Polyethylene inlay exchange was performed due to routine.No femoral or tibial component was extracted.
Additional Manufacturer Narrative
Results of investigation: the device was not returned for evaluation and the reported event could not be confirmed.The contribution of the device to the reported event could not be corroborated.The clinical/medical evaluation concluded that per the crf (adverse event form/plate #100/(ae #3) the patient experienced moderate knee pain secondary to patellar mal-tracking with lateralization and low patellar tilt noted on 5-year x-ray, which was ¿possibly related to the study device and/or procedure¿.The (ae #3) onset was documented as 01/01/2017, without medication or procedure treatment at that time.However, the crf (radiographic form/plate#80) dated 01/20/2020 noted osteophytes in addition to the mal-positioned native patella for which a revision was performed approximately 6 years post right tka.Per correspondence, the native patella was resurfaced/component implanted along with a routine insert explant/replacement and the explanted insert is not available for evaluation.Although the event was reported as possibly device and procedure related, the x-ray findings suggests disease progression which is a known potential occurrence of a non-resurfaced patella in the presence of knee prosthetic components and is not a failure of the implanted devices.No further medical documentation has been received as of the date of this medical investigation.The patient impact beyond the reported findings/events could not be determined.No further assessment can be rendered at this time.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 similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed this failure mode was previously identified.A historical review concluded that there are no prior actions related to this product and event.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 or disease progression.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.Correction in h.
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 evaluation concluded that per the crf (adverse event form/plate #100/(ae #3) the patient experienced moderate knee pain secondary to patellar mal-tracking with lateralization and low patellar tilt noted on 5-year x-ray, which was ¿possibly related to the study device and/or procedure¿.The (ae #3) onset was documented as 01/01/2017, without medication or procedure treatment at that time.However, the crf (radiographic form/plate#80) dated 01/20/2020 noted osteophytes in addition to the mal-positioned native patella for which a revision was performed approximately 6 years post right tka.Per correspondence, the native patella was resurfaced/component implanted along with a routine insert explant/replacement and the explanted insert is not available for evaluation.Although the event was reported as possibly device and procedure related, the x-ray findings suggests disease progression which is a known potential occurrence of a non-resurfaced patella in the presence of knee prosthetic components and is not a failure of the implanted devices.No further medical documentation has been received as of the date of this medical investigation.The patient impact beyond the reported findings/events could not be determined.No further assessment can be rendered at this time.A review of complaint history did not reveal additional complaints for the listed batch for the same failure mode.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 and potential harm was previously identified.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 or product information, 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 FEMORAL OXIN RT SZ 3
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 1450 brooks road; memphis, TN 38116 ; 5123913905
• MDR Report Key: 11612124
• Report Number: 1020279-2021-02658
• Device Sequence Number: 3396556
• Product Code: JWH
• UDI-Device Identifier: 00885556179017
• UDI-Public: 00885556179017
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2022

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 Expiration Date: 06/04/2024
• Device Model Number: 74027231
• Device Catalogue Number: 74027231
• Device Lot Number: 14FM04972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 06/29/2021; 02/02/2022
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 06/30/2021; 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74022113 JRNY II BCS FEMORAL L#13HM08892; 74022213 JOURNEY TIBIA BASE L#14DM16137
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Female
• Patient Weight: 64 KG