MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY UNI TIBIAL BASE LM/RL SZ 3; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71422423

Device Problems Degraded (1153); Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional information: exact date of implantation is not known, it was reported that it happened somewhere in (b)(6) 2015; exact date of explantation is not known, it is reported that it happened somewhere in (b)(6) 2017.

Event Description

It was reported that a revision took place due to poly dislocation/luxation, wear and metallosis.

• Brand Name: JRNY UNI TIBIAL BASE LM/RL SZ 3
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, 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: claudia de santis ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6431870
• MDR Text Key: 70781157
• Report Number: 1020279-2017-00213
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K102069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/29/2015
• Device Model Number: 71422423
• Device Catalogue Number: 71422423
• Device Lot Number: 15FM00425
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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
• Treatment: 71422346, JUNI OX FB FEM SZ 6 LM RL, LOT: 14KM0062
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR