MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP RT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Catalog Number	74021154
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka had been performed by implanting a journey ii system, the clinical subject experienced deep scar formation due to a fall.The event was treated via procedure: synovectomy.The situation is considered resolved.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A review of complaint history on the listed part revealed no prior complaints for the listed batch with 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.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further investigation warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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 investigation concluded that per complaint details, the clinical subject experienced deep scar formation due to a right knee fall approximately 1 month post right jrny ii cr tka.Per the crf, the onset of swelling (ae#1) was (b)(6) 2018 and deep scar formation (ae#2) onset was (b)(6) 2018 with resolution of both as of (b)(6) 2019.Reportedly, a synovectomy was performed and ¿the situation is considered resolved¿ without further interventions.No further clinically relevant documentation was provided for inclusion in the medical investigation.Based on the information provided, the relationship to the fall could not be definitively concluded and the reported fall could not be ruled out as a contributing factor to the reported event.However, the information provided does not support a mal-performance of the right tka components.The patient impact beyond the reported fall, symptoms, and subsequent synovectomy could not be determined.No further medical assessment could be rendered at this time.A review of complaint history did not reveal additional complaints for the listed batch.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 CR FEM OX NP RT SZ 4
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10082455
• Report Number: 1020279-2020-01835
• Device Sequence Number: 3384504
• Product Code: JWH
• UDI-Device Identifier: 00885556422854
• UDI-Public: 885556422854
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2021

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: 09/20/2026
• Device Catalogue Number: 74021154
• Device Lot Number: 16JM11921
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 01/28/2021; 07/01/2021
• Initial Report FDA Received Date: 05/22/2020
• Supplement Report FDA Received Date: 02/01/2021; 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 82