MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN JOURNEY BCS KNEE INSERT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 10/19/2021

Event Type  Injury  

Manufacturer Narrative

Reference number: (b)(4).

Event Description

It was reported that, after a tka (date unknown), the unknown journey bcs knee insert broke, and it was replaced on a revision surgery performed on (b)(6) 2021.Current health status of the patient is unknown.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, it was reported that after a tka on an unknown date, the patient had a revision due to an unknown journey bcs knee insert being broken.No further clinical/medical documentation was provided for review.Without supporting medical documentation, a thorough medical assessment cannot be performed.In the event additional medical/clinical records are received, the clinical task may be re-opened, and a thorough assessment will be rendered at that time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.The contribution of the device to the reported event could not be corroborated.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.We consider this investigation closed.

• Brand Name: UNKN JOURNEY BCS KNEE INSERT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 12779707
• MDR Text Key: 280527989
• Report Number: 1020279-2021-07922
• Device Sequence Number: 1
• Product Code: HRY
• 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: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 02/11/2022
• Supplement Dates FDA Received: 02/14/2022
• 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
• Patient Outcome(s): Hospitalization; Required Intervention