MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN JOURNEY KNEE TIBIAL; PROSTHESIS, KNEE, PATELLOFEM, SEMI-CONSTRAINED, CEMENTED, POLY/METAL/POLY

Catalog Number UNKNOWN

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Date 10/13/2021

Event Type  Injury  

Manufacturer Narrative

Reference number: case- (b)(4).

Event Description

It was reported that, after a tka surgery was performed on (b)(6) 2016, a revision surgery had to be conducted on (b)(6) 2021 due to loosening of poly.There was visible damage to the femoral component.The surgeon decided that a complete revision was necessary.Patient current health status is unknown.

Manufacturer Narrative

H3, h6: the associated device was not returned for evaluation and the reported event could not be confirmed.The contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing, lack of ingrowth and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: UNKN JOURNEY KNEE TIBIAL
• Type of Device: PROSTHESIS, KNEE, PATELLOFEM, SEMI-CONSTRAINED, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12746990
• MDR Text Key: 279938557
• Report Number: 1020279-2021-07824
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 74021157 - JRNY II CR FEM OX NP RT SZ 7; UNKN JOURNEY KNEE INSERT; 74021157 - JRNY II CR FEM OX NP RT SZ 7; UNKN JOURNEY KNEE INSERT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male