MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S3-4RM/LL9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71422256

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2020

Event Type  Injury  

Event Description

It was reported that during surgery, the surgeon was unable to seat the poly liner and had to remove it.The liner was damaged in the process of removing.A back up device was available and the case was completed without further incident.A five minute delay was reported.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this case reports that the tibial insert was unable to be seated.Per complaint details, the insert was damaged while removing it.The procedure was completed using another insert.There was a 5-minute delay and no patient harm was reported.Therefore, no further assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.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 a fit/ sizing issue or poor insertion technique.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: JOURNEY UNI TIBINRT S3-4RM/LL9MM
• 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: 10518678
• MDR Text Key: 206472570
• Report Number: 1020279-2020-04537
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010582171
• UDI-Public: 03596010582171
• 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: 06/30/2021

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
• Device Model Number: 71422256
• Device Catalogue Number: 71422256
• Device Lot Number: 17JM11560
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 06/30/2021
• Supplement Dates FDA Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention