MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR INS XLPE MED 5-6 RT 9MM; PRSTHSIS,KNEE,PATLLFMROTIBIAL,SMI-CNSTRND,CMNTD,PLYMR/METAL/POLYMER

Catalog Number 74023751

Device Problem Insufficient Information (3190)

Patient Problem Inflammation (1932)

Event Date 05/30/2018

Event Type  Injury  

Event Description

It was reported that due to right knee inflammation the patient has been given medications such as vicodin and prednisone.

Manufacturer Narrative

The associated complaint devices were not returned for evaluation.A clinical evaluation noted no clinical information has been provided for inclusion in this investigation.The patient currently remains in the study.No further clinical/medical assessment is warranted at this time.A review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.Our investigation included a review of the manufacturing records for the listed batches which did not reveal any deviation from the standard manufacturing processes.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: JRNY II XR INS XLPE MED 5-6 RT 9MM
• Type of Device: PRSTHSIS,KNEE,PATLLFMROTIBIAL,SMI-CNSTRND,CMNTD,PLYMR/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0110447940
• MDR Report Key: 7689761
• MDR Text Key: 114035491
• Report Number: 1020279-2018-01289
• Device Sequence Number: 1
• Product Code: JDH
• UDI-Device Identifier: 00885556613115
• UDI-Public: 00885556613115
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74023751
• Device Lot Number: 16BM19446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR