MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 7-8 LT 9MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL

Catalog Number 74027281

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 12/22/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery of the insert was performed due to knee contracture.There is no damage but adhesion of the soft tissue on the insert.The surgeon decided it is not the product failure.

Manufacturer Narrative

Add'l info: the associated complaint device was not returned for evaluation.Please see attached file for our results of investigation.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 7-8 LT 9MM
• Type of Device: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL
• 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 rd; memphis, TN 38116
• MDR Report Key: 7155324
• MDR Text Key: 96065337
• Report Number: 1020279-2017-01365
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556178317
• UDI-Public: 00885556178317
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74027281
• Device Lot Number: 15LM11806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/25/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 100