MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM; PROSTHE, KNEE, PATELLOFEMOL, SEMI-CONS, CEMENTED, POLY/METAL/POLY

Model Number	74027231
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision was performed because the patient jumped off a horse and fell on the frozen ground on the right knee with the prosthesis.During the revision, the tibial baseplate component showed excellent cement adherence.The tibial baseplate and articular insert were revised as planned.
Additional Manufacturer Narrative
The devices, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.The devices were manufactured in 2015 and 2016.The devices were replaced in a revision surgery.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.It was stated that the patient jumped off a horse and fell on the frozen ground on the right knee with the prosthesis.The potential probable cause of this event is likely a traumatic injury/ fall.Our clinical/medical team noted: it has been communicated that no clinical documents are available.Therefore, no thorough clinical assessment of the reported issue can be rendered.Should additional information be provided, the clinical/medical investigation task will be reopened.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM
• Common Device Name: PROSTHE, KNEE, PATELLOFEMOL, SEMI-CONS, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9587384
• Report Number: 1020279-2020-00265
• Device Sequence Number: 2525553
• Product Code: JWH
• UDI-Device Identifier: 00885556179017
• UDI-Public: 00885556179017
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

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: No Information
• Device Expiration Date: 08/11/2025
• Device Model Number: 74027231
• Device Catalogue Number: 74027231
• Device Lot Number: 15HM10142
• Initial Date Received by Manufacturer: 12/28/2019
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 10/13/2020
• 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