MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR LOCK FEM IMPLANT IMPACTOR; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number 74011711

Device Problem Misassembled (1398)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2019

Event Type  malfunction  

Event Description

It was reported that plastic snap rings on the locking mechanism have come apart.

Manufacturer Narrative

After further review by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The event occurred during inspection with no patient involvement, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

Manufacturer Narrative

The associated complaint device was not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.Credit cannot be issued for this device.

• Brand Name: JRNY II CR LOCK FEM IMPLANT IMPACTOR
• Type of Device: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8327601
• MDR Text Key: 135873520
• Report Number: 1020279-2019-00517
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556422892
• UDI-Public: 00885556422892
• Combination Product (y/n): N
• PMA/PMN Number: K121443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 74011711
• Device Lot Number: 13CBG0042
• Initial Date Manufacturer Received: 01/21/2019
• Initial Date FDA Received: 02/11/2019
• Supplement Dates Manufacturer Received: 01/21/2019; 01/21/2019
• Supplement Dates FDA Received: 05/03/2019; 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1