MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE LT SZ 3-4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74025641
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after tka surgery had been performed on (b)(6) 2016, the clinical subject experienced aseptic loosening of knee prosthesis that ended up been treated with a left knee revision surgery on (b)(6) 2020.The issue was resolved.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the patient underwent liner and patellar revision due to severe adverse event (ae#2) left knee aseptic loosening and instability approximately 4.5 years post implantation.Per the provided operative crfs, during the primary dcf tka the mcl, pm corner releases and pcl released off the bone.It is unknown if the releases could have contributed to the reported instability.It was documented that the start and stop date of the (ae#2) was 9/28/2020; however, the study participation was reportedly discontinued due to the reported event and the patient outcome was unknown.Based on the information provided, the root cause of the reported events could not be definitively concluded.The patient impact beyond the reported aseptic loosening, instability and subsequent revision could not be determined.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.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 did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.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 ISRT XLPE LT SZ 3-4 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11907591
• Report Number: 1020279-2021-04817
• Device Sequence Number: 4381195
• Product Code: JWH
• UDI-Device Identifier: 00885556422533
• UDI-Public: 00885556422533
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2022
• Device Model Number: 74025641
• Device Catalogue Number: 74025641
• Device Lot Number: 12HM07564
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 05/31/2021
• Supplement Report FDA Received Date: 08/12/2021
• 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 Weight: 118