MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR INS XLPE LAT 7-8 LT 9MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLY/METAL/POLY

Catalog Number 74023881

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Injury (2348); Neck Stiffness (2434)

Event Date 06/19/2017

Event Type  Injury  

Event Description

It was reported that after 8 weeks post-op, the patient still had limited range of motion after aggressive physical therapy, for which manipulation under anesthesia was required due to the stiffness.

Manufacturer Narrative

The associated complaint devices were not returned.A clinical evaluation was conducted and details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.No cardiac markers or labs have been submitted either.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported stiffness and myocardial infarction cannot be determined.Root cause of the arthrofibrosis could be contributed to concomitant medical problems, rehabilitation, and history (bilateral hip replacement, bilateral knee meniscus repair, bilateral knee osteoarthritis, hypertension, mi) patient impact: 1) arthrofibrosis and mua 2) myocardial infarction treated with bypass and stent placement procedure with a hospital stay both incidents are listed as having been resolved.No further medical assessment is warranted based on the information provided.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.

• Brand Name: JRNY II XR INS XLPE LAT 7-8 LT 9MM
• Type of Device: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8725623
• MDR Text Key: 148900611
• Report Number: 1020279-2019-02408
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556615850
• UDI-Public: 00885556615850
• Combination Product (y/n): N
• PMA/PMN Number: K152726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74023881
• Device Lot Number: 16BM16077
• Date Manufacturer Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 69 YR