MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS CNSTRD ART ISRT 3-4 LT 10M; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74029242
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to exchange the insert to a thicker one as patient was experiencing small looseness.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation; reporting event could not be confirmed a clinical evaluation was conducted and confirms without the requested clinical information a thorough medical investigation cannot be rendered.Should any additional clinical information be provided this complaint will be re-evaluated.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Factors and/or potential probable causes that could have contributed to the reported event include but are not limited to lock detail geometry and too much clearance in areas of posterior dovetail cross section.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.

• Brand Name: JRNY II BCS CNSTRD ART ISRT 3-4 LT 10M
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9135170
• Report Number: 1020279-2019-03507
• Device Sequence Number: 14148713
• Product Code: JWH
• UDI-Device Identifier: 00885556176061
• UDI-Public: 00885556176061
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

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: Health Professional
• Device Model Number: 74029242
• Device Catalogue Number: 74029242
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 04/22/2020
• 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