MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S5-6LM/RL10MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71422263

Device Problem Fitting Problem (2183)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/10/2020

Event Type  malfunction  

Event Description

It was reported that, during a surgery, the journey uni tibinrt s5-6lm/rl10mm insert did not become fixed into the tibial component.It is unknown how the procedure concluded, if there was a delay or an injury.

Manufacturer Narrative

H3, h6: the device, intended for use in treatment was returned for evaluation: a visual was conducted and confirmed the journey uni tibinrt s5-6lm/rl10mm did not fit into the component.A dimensional inspection was attempted but the device was too damaged from the attempted insertion to obtain accurate measurements.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JOURNEY UNI TIBINRT S5-6LM/RL10MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10382831
• MDR Text Key: 202162927
• Report Number: 1020279-2020-03805
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010582225
• UDI-Public: 03596010582225
• Combination Product (y/n): N
• PMA/PMN Number: K061011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2020
• Device Model Number: 71422263
• Device Catalogue Number: 71422263
• Device Lot Number: 10KM04576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1