MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR INS XLPE LAT 1-2 LT 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POL/M/POL

Model Number	74023822
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery had been performed, there was a dislocation.It is believed that the baseplate had been set with wrong degree.A revision surgery was performed to treat the adverse event.The journey ii xr ins xlpe lat 1-2 lt 10mm insert was exchanged.
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 medical investigation was conducted and confirms this complaint reports a tka revision due to dislocation.Per email communication, it is confirmed that he surgeon confirmed that the baseplate was set at the wrong degree during primary implantation.However, there the requested x-rays and surgical reports are not available.Therefore, no further assessment is able to be performed 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.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.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 actions are being taken at this time.We consider this investigation closed.

• Brand Name: JRNY II XR INS XLPE LAT 1-2 LT 10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POL/M/POL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10399878
• Report Number: 1020279-2020-03901
• Device Sequence Number: 2757793
• Product Code: JWH
• UDI-Device Identifier: 00885556615577
• UDI-Public: 00885556615577
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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 Model Number: 74023822
• Device Catalogue Number: 74023822
• Device Lot Number: 16EM10871
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 06/19/2021
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 06/22/2021
• 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