MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S3-4LM/RL9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71422252

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2024

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, during tka surgery, a grey tipped flat tibial impactor was used on journey uni tibinrt s3-4lm/rl9mm to engage implant posteriorly.Following this, it was unable to engage locking mechanism of insert anteriorly.There was no debris on tibial plate that could be impeding it.After a few attempts to lock insert to tibial base plate, a new insert was used, which locked in straight away.On inspection of implant, it appeared that anterior locking mechanism was broken.Initially, it was discussed that this was likely compromised when it was impacted posteriorly to tibial base plate.Further discussions revealed that the implant could be potentially malformed/ faulty (at anterior locking portion) prior to impacting and then this was likely exacerbated when the impaction took place.The procedure was resumed, after a non-significant delay, with a s+n back-up device.Patient was not injured as consequence of this problem.

• Brand Name: JOURNEY UNI TIBINRT S3-4LM/RL9MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-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: 19202543
• MDR Text Key: 341291620
• Report Number: 1020279-2024-00846
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010582133
• UDI-Public: 03596010582133
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K061011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71422252
• Device Lot Number: 22JM01117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2024
• Date Device Manufactured: 09/01/2022
• 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