MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S5-6LM/RL9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71422262

Device Problem Positioning Failure (1158)

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

Event Date 04/17/2023

Event Type  malfunction  

Event Description

It was reported that, during a tka surgery, one (1) journey uni tibinrt s5-6lm/rl9mm was not locking.The procedure was resumed, after a delay greater than 30 minutes, with a s+n back-up device.No injury was reported as a consequence of this issue.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

This complaint has been reassessed based on additional information gathered by the manufacturer.It was determined that this event does not fulfill reporting requirements per 21 cfr §803 regulations.The malfunction originated a surgical delay less than 30 minutes that did not lead to death or serious injury, nor it would likely cause or contribute to death or serious injury if it were to recur.

Event Description

It was reported that, during a tka surgery, one (1) journey uni tibinrt s5-6lm/rl9mm was not locking.The procedure was resumed, after a 20 minute delay, with a s+n back-up device.No injury was reported as a consequence of this issue.

• Brand Name: JOURNEY UNI TIBINRT S5-6LM/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: 16812034
• MDR Text Key: 314000317
• Report Number: 1020279-2023-00929
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010582218
• UDI-Public: 03596010582218
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71422262
• Device Catalogue Number: 71422262
• Device Lot Number: 21GM05056
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• 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