MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM COCR NP RT SZ 5; PROST, KNEE, PATFEMTIB, SEMI-CNSTRND, CMNTD, POLY/MET/POLY

Model Number	74021255
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Joint Dislocation (2374)
Date of Event	11/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a right tka performed on (b)(6) 2020, due to extensive valgus, synovitis, and gonarthrosis in the right retropatellar, the patient experienced patellar pain on motion accentuated laterally with a sticky crunch and synovitis.Also, the patellar component was not located in the femoral notch.The patient underwent revision surgery on (b)(6) 2022 to replace knee components.The patient's outcome is unknown.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that, after a right tka performed on (b)(6) 2020, due to extensive valgus, synovitis, and gonarthrosis in the right retropatellar, the patient experienced patellar pain on motion accentuated laterally with a sticky crunch and synovitis.Also, the patellar component was not located in the femoral notch.The patient underwent revision surgery on (b)(6) 2022 to replace knee components.Explants were not provided upon request.
Additional Manufacturer Narrative
Results of investigation: the device was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that based on the information provided, its noted that patella resurfacing was not performed at the time of the tka.The root cause of the reported symptoms cannot be confirmed however, the retropatellar arthrosis/disease progression with the patella ¿not located in the femoral notch¿ contributed to the reported pain and led to the resurfacing of the patella.It should be noted; however, that the implantation of the retropatellar prosthesis does not represent a component mal-performance or failure.The patient impact beyond the reported symptoms, additional surgical procedure and inlay revision could not be determined, as the current patient status is unknown.No further medical 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 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 device.A review of the risk management file and instructions for use documents 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 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, patient anatomy or abnormal loading of limb.The contribution of the device to the reported event could not be corroborated.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.

• Brand Name: JRNY II CR FEM COCR NP RT SZ 5
• Common Device Name: PROST, KNEE, PATFEMTIB, SEMI-CNSTRND, CMNTD, POLY/MET/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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13573241
• Report Number: 1020279-2022-00792
• Device Sequence Number: 4018834
• Product Code: JWH
• UDI-Device Identifier: 00885556615171
• UDI-Public: 00885556615171
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74021255
• Device Catalogue Number: 74021255
• Device Lot Number: B1814700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2018
• 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: 74022214 / JOURNEY TIBIA BASE NP RT SZ 4; 74025732 / JRNY II ISRT XLPE DD RT SZ 3-4 10MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 105 KG