MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S5-6RM/LL8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71422265

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 12/06/2018

Event Type  Injury  

Event Description

Legal (b)(6).It was reported that patient had a knee replacement on (b)(6) 2018, where he had a baring locking mechanism fitted.Shortly after the surgery the baring locking mechanism failed causing the claimant to suffer from severe pain.This required the patient to undergo a second surgery on (b)(6) 2018 which failed again, a third operation was required on (b)(6) 2018.

Manufacturer Narrative

The associated complaint devices were not returned.A clinical evaluation was conducted and it has been communicated via email that no relevant supporting clinical information will be provided, and there is no report of the patient's current condition.Therefore based on insufficient information, no further clinical assessment can be performed at this time.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

Event Description

It was reported that patient had a knee replacement on (b)(6) 2018, where he had a baring locking mechanism fitted.Shortly after the surgery the baring locking mechanism failed causing the claimant to suffer from severe pain.This required the patient to undergo a second surgery on (b)(6) for an insert exchange.

Manufacturer Narrative

This case has been re-opened upon receipt of new medical records.However, the medical records received were incomplete, and did not provide information regarding the primary implantation, nor the first revision procedure.The records indicate that 5 months following the first revision, the patient ¿felt something go within the knee¿, had restricted rom and difficulty walking, which required a second revision.It was reported at the 6 week follow-up that x-rays confirm good position of the components.A clinical analysis noted that based on the limited information provided and reviewed, the root cause of the right uni knee revision cannot be determined.Without the return of the device for evaluation and the complete supporting medical documentation requested, the cause of the reported recurrent dislocations cannot be concluded.No further clinical assessment is warranted at this time.We consider this investigation closed.However, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

Manufacturer Narrative

The associated journey uni tibial insert was not returned for evaluation.Therefore the product analysis could not be performed.However, device details were provided.Thus, the review of manufacturing records was conducted which did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.A clinical evaluation was conducted and it has been communicated via email that no clinical information is available for consideration in the clinical/medical assessment.Therefore, a thorough medical assessment can not be rendered at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.

Manufacturer Narrative

Additional information was received and assessed.Updated results of investigation: it was reported that patient had a revision surgery due to severe pain as the locking mechanism failed.The associated journey uni tibial insert, used for treatment, was not returned for evaluation.Therefore the product analysis could not be performed.However, device details were provided.Thus, the review of manufacturing records was conducted and it did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.A clinical evaluation was conducted and noted the medical records received were incomplete, and did not provide information regarding the primary implantation, nor the first revision procedure.It was reported at the 6 week follow-up that x-rays confirm good position of the components.No further medical assessment can not be rendered at this time.Possible causes could include but not limited to size of device or user/procedural variance.Without the return of the actual product involved, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.

Manufacturer Narrative

Updated results of investigation due to new received information: it was reported that the patient underwent a revision approx.2 months post-implantation due to dislocation.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.A review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.This reported failure has been identified in the ifu and rmp files as potential adverse events.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A clinical evaluation noted the medical records received were incomplete, and did not provide information regarding the primary implantation.The records indicate that 5 months following the first revision, the patient ¿felt something go within the knee¿, had restricted rom and difficulty walking, which required a second revision.It was reported at the 6 week follow-up that x-rays confirm good position of the components.Based on the information provided and reviewed, the root cause of the dislocations which resulted in 2 revisions cannot be determined.No further medical assessment can not be rendered at this time.Without the return of the actual product involved and no complete medical records provided, our investigation of this report is inconclusive.Some potential causes of the reported event could include but are not limited to traumatic injury, patient anatomy or abnormal loading of limb.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.We consider this investigation closed.

• Brand Name: JOURNEY UNI TIBINRT S5-6RM/LL8MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8213183
• MDR Text Key: 131945320
• Report Number: 1020279-2019-00025
• Device Sequence Number: 1
• Product Code: HSX
• 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,Followup,Followup,Followup
• Report Date: 06/25/2020

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 Catalogue Number: 71422265
• Device Lot Number: 15CM13290
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 12/06/2018; 05/01/2019; 05/01/2019; 05/01/2019; 05/01/2019; 05/01/2019
• Supplement Dates FDA Received: 04/10/2019; 05/31/2019; 08/05/2019; 12/06/2019; 02/01/2020; 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention