MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE LT SZ 1-2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74025621
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	06/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka was performed on (b)(6) 2019 where a jrny ii cr isrt xlpe lt sz 1-2 9mm, a journey tibia base np lt sz 2 and a jrny ii cr fem ox np lt sz 3 were implanted, the patient experienced pain.A revision surgery was performed on (b)(6) 2023.It was found that the insert showed wear.All products were exchanged for a competitor's devices.Patient current health status is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference: case(b)(4).
Additional Manufacturer Narrative
The devices were not returned for evaluation.However, the photographs were reviewed, and revealed that the insert, the tibial baseplate and the femoral component show signs of significant wear.The clinical/medical investigation concluded that, based on the information and photos provided, the insert deformation along with wear of the oxinium femoral condyle is suspicious of insert disassociation with third body debris/wear or articulation that isn¿t centered on the insert and would have contributed to the reported pain.The femoral component is noted to have partial cement adherence; however, it is unknown if there was actual femoral component loosening.The patient impact included the reported pain, a suspected disassociated insert with third body debris/wear and revision.Further impact to the patient could not be determined, although postoperative restorative therapy would be anticipated.No further medical assessment can be rendered at this time.For the insert and the tibial baseplate, 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, device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.For the insert and the tibial baseplate, a review of complaint history revealed a similar event for the listed devices over the previous 12 months, but no similar events for the batches based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.For the femoral component, a review of complaint history of the previous 12 months revealed a similar event for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed in possible adverse effects that wear of the polyethylene articulating surfaces of knee replacement components has been reported following total knee replacement.Higher rates of wear may be initiated by particles of cement, metal, or other debris which can cause abrasion of the articulating surfaces.Higher rates of wear may shorten the useful life of the prosthesis, and lead to early revision surgery to replace the worn prosthetic components.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 friction or joint tightness.Based on this investigation, the need for corrective action is not indicated.Should the devices 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 CR ISRT XLPE LT SZ 1-2 9MM
• 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: 17358440
• Report Number: 1020279-2023-01475
• Device Sequence Number: 20561095
• Product Code: JWH
• UDI-Device Identifier: 00885556422670
• UDI-Public: 00885556422670
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 08/18/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74025621
• Device Catalogue Number: 74025621
• Device Lot Number: 18EM18563
• 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: 06/30/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2018
• 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: JOURNEY TIBIA BASE NP LT SZ 2 (PN: 74022222).; JRNY II CR FEM OX NP LT SZ 3 (PN:74021163).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female