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

Model Number	71422262
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1020279-2023-00929
• Device Sequence Number: 12183291
• Product Code: HSX
• UDI-Device Identifier: 03596010582218
• UDI-Public: 03596010582218
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown