MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 RT 13MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CEMENTD,POLYMR/METAL/POLYMER

Catalog Number 74027255

Device Problem Material Too Rigid or Stiff (1544)

Patient Problems Injury (2348); Limited Mobility Of The Implanted Joint (2671)

Event Date 02/19/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to stiffening of the knee.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.No clinical supporting documents were provided to conduct a thorough analysis of the reported issue.Per the surgeon, this issue is not the device related.No further actions are being taken at this time.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 5-6 RT 13MM
• Type of Device: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CEMENTD,POLYMR/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: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7312359
• MDR Text Key: 101458905
• Report Number: 1020279-2018-00262
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556179567
• UDI-Public: 00885556179567
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74027255
• Device Lot Number: 15KM07739
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/12/2015
• 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): Hospitalization; Required Intervention