MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY II BCS TIBIA LEFT SZ 1-2; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, METAL/POLYMER

Catalog Number 71422424

Device Problems Unstable (1667); Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 08/21/2018

Event Type  Injury  

Event Description

It was reported that a implant bilateral surgery was perform on (b)(6) 2012.A revision surgery was performed on (b)(6) 2018 in the right hip.The left hip has not been revised.No further information available.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per the revision operative report - the tibia was loose ¿ the femoral component was tight and was removed with micro-oscillating saw and osteotomes.Meniscus and bone spurs were removed on the lateral side.This was done 2 years and 8 months post implantation.No x-rays or other medical documentation was provided for the knee revision.There was no report of a trauma or incident that might have loosened the component.The impact to the patient beyond the surgery and recovery cannot be determined at this time.In conclusion, based on the limited information for this procedure, the root cause of the ¿loosening¿ of the tibial plate cannot be concluded.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.Factors and/or some potential probable causes that could contribute to the reported event have been identified as but not limited to abnormal motion over time, bone degeneration, fit/sizing, lack of ingrowth, lifetime of device, and traumatic injury.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.

Event Description

It was reported that the patient underwent a tka revision surgery on (b)(6) 2014.The revision surgery was performed due to implant failure, the tibial baseplate was loose.All the s&n components were explanted and replaced with a competitors devices.The patient outcome is unknown.

• Brand Name: JOURNEY II BCS TIBIA LEFT SZ 1-2
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis, tn
• MDR Report Key: 10411617
• MDR Text Key: 203084416
• Report Number: 1020279-2020-03894
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00885556581131
• UDI-Public: 885556581131
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71422424
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEUCE FEM 71422206 / LOT UNKNOWN; GEN II PATELLAR 71932635 / LOT 11JM13263; JOURNEY UNI TIBINRT 71422253 / LOT UNKNOWNLOT; JRNY II BCS FEM 74010106KT/ LOT
• Patient Outcome(s): Hospitalization; Required Intervention