MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP RT SZ 8; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74021158
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/01/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a tka surgery was performed the patient experienced on the right knee pain and stiffness, the issue was resolve by manipulation under anesthesia.The outcome of the patient was resolved with residual effects.
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that after a tka surgery was performed the patient experienced on the right knee pain and stiffness, the issue was resolve by manipulation under anesthesia.The outcome of the patient was resolved with residual effects.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details an mua (manipulation under anesthesia) was performed due to right knee pain and stiffness an unknown duration of time post tka.The provided crfs were reviewed; however, do not provide insight into the reported right knee pain and stiffness.Per the crfs, there were no technical difficulties during the procedure performed on (b)(6) 2015.Arthrofibrosis is a known possible post-surgical occurrence, and the provided documentation does not support a component mal-performance.Reportedly, the ¿outcome: resolved with residual effects¿.The root cause of the reported events could not be definitively concluded based on the limited information provided.The patient impact beyond that which was reported cannot be determined.No further medical investigation could 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 instructions for use documents for knee systems revealed that stiffness has been identified as a possible adverse effects.A review of the risk management file 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, material in use, patient reaction, alignment, fit/size of device used, wear or loss of sterility.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 OX NP RT SZ 8
• 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: 13515555
• Report Number: 1020279-2022-00658
• Device Sequence Number: 4474287
• Product Code: JWH
• UDI-Device Identifier: 00885556422816
• UDI-Public: 00885556422816
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2022

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 Expiration Date: 04/24/2025
• Device Model Number: 74021158
• Device Catalogue Number: 74021158
• Device Lot Number: 15DM18039
• 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: 01/24/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 03/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2015
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Unknown
• Patient Weight: 84 KG