MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP LT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74021165
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	10/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Study: new journey ii cr study id: (b)(6) subject: (b)(6) ae: 8.It was reported that, after a tka surgery performed on (b)(6) 2016, the patient started experiencing, on (b)(6) 2021, an intermittent achiness of the left knee at night; these events have been reported to be of mild severity.It is unknown if the patient has been given any treatments, interventions or medications to treat this adverse event.The patient's conditions have been reported as unresolved.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the devices were not returned for evaluation.The clinical/medical investigation concluded that, the clinical study documents were reviewed.However, it did not provide any clinical insight into the reported issue of intermittent achiness of the left knee at night that started approximately five years post total knee arthroplasty.Therefore, there were no clinical factors identified which would have contributed to the reported event.Reportedly, the patient uses a wool wrap to treat the pain.The patient impact includes the pain, use of wool wrap.Future impact cannot be determined since the adverse event is unresolved and ongoing.No further clinical 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 the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the femoral head, a review of complaint history revealed a similar event for the listed device over the previous 12 months, but no similar events for the batch based on the historical data.For the base plate and insert, a review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed devices.For the patella, a review of complaint history based on the historical data revealed a similar event for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to these products and event.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness or, patient condition.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.We consider this investigation closed.
Additional Manufacturer Narrative
Results of investigation: given the nature of the alleged incident, the devices were not returned for evaluation.The clinical/medical investigation concluded that, the clinical study documents were reviewed.However, it did not provide any clinical insight into the reported issue of intermittent achiness of the left knee at night that started approximately five years post total knee arthroplasty.Therefore, there were no clinical factors identified which would have contributed to the reported event.Reportedly, the patient uses a wool wrap to treat the pain.The patient impact includes the pain, use of wool wrap.Future impact cannot be determined since the adverse event is unresolved and ongoing.No further clinical 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 the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the femoral component, a review of complaint history revealed a similar event for the listed device over the previous 12 months, but no similar events for the batch based on the historical data.For the base plate and insert, a review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed devices.For the patella, a review of complaint history based on the historical data revealed a similar event for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to these products and event.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness or, patient condition.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.We consider this investigation closed.

• Brand Name: JRNY II CR FEM OX NP 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18192558
• Report Number: 1020279-2023-02299
• Device Sequence Number: 7247007
• Product Code: JWH
• UDI-Device Identifier: 00885556422786
• UDI-Public: 00885556422786
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2023

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: 11/01/2025
• Device Catalogue Number: 74021165
• Device Lot Number: 15LM03001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 12/13/2023; 12/13/2023
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 12/14/2023; 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2015
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 74022223 / LOT: 16HM13628.; PN: 74024832 / LOT: 16GM10471.; PN: 74025641 / LOT: 15MM12126.
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 76 KG