MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S5-6LM/RL8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71422261

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091)

Event Date 01/30/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery on left knee was performed due to pain and swelling.Patient was treated with a joint injection on (b)(6) 2018.Since the issue wasn't resolved with the injection, dr decided to perform a surgical procedure on (b)(6) 2018 to remove the parts.

Manufacturer Narrative

The associated complaint devices were not returned.The clinical/medical team concluded, the intra-operative findings noted during the revision were: pain, swelling, severe metal debris throughout the entire synovium staining all the available tissue black, and scar tissue of the patella fat pads maybe consistent with an adverse reaction to metal debris but could be a result of the disassociated liner.Without the supporting metal ion levels/pathology results, imaging, and/or the analysis of the explanted components, the cause of the failure cannot be confirmed.The patient impact beyond the revision cannot be concluded.No further clinical/medical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

Manufacturer Narrative

Additional information: the associated complaint devices were returned and evaluated.A lab analysis was conducted and the cause of the reported pain and swelling could not be determined from the information provided.The observed damage to the articular surface of the femoral component and the proximal surface of the tibial baseplate likely occurred following the reported dislocation of the insert.Based on the damage observed on the locking detail, it is unclear if the tibial insert was fully engaged into the tibial baseplate.No material or manufacturing deviations were observed in the course of this investigation.A clinical evaluation was conducted and this compliant was re-opened due to the receipt of the legal claim.The new information has been reviewed and acknowledged.However, it does not add or contribute to the medical assessment previously approved by (b)(6) on (b)(6) 2018, or contribute to its conclusion.Should any additional clinical information be provided this complaint will be re-assessed.A review of complaint history on the listed parts revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Should information become available this complaint can be re-assessed.Available this complaint can be re-assessed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: JOURNEY UNI TIBINRT S5-6LM/RL8MM
• 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: 7724618
• MDR Text Key: 115186142
• Report Number: 1020279-2018-01434
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010582201
• UDI-Public: 03596010582201
• Combination Product (y/n): N
• PMA/PMN Number: K061011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2019

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: 71422261
• Device Lot Number: 16GM16917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 07/26/2018
• Supplement Dates Manufacturer Received: 07/17/2018; 07/17/2018
• Supplement Dates FDA Received: 11/19/2018; 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PART NUMBER 71422345 / LOT NUMBER 16JM02144A.; PART NUMBER 71422425 / LOT NUMBER 14EM19202.
• Patient Outcome(s): Hospitalization; Required Intervention