MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENGAGE POROUS TIBIAL TRAY SZ 4-RT MED; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 1-10012-450

Device Problem Failure to Osseointegrate (1863)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 11/29/2023

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

Event Description

It was that, after a uka had been performed on (b)(4) 2023, the patient underwent a revision surgery to a tka on (b)(4) 2023, due to the engage porous tibial tray sz 4-rt med not being ingrown and had startup pain.In addition, one (1) engage tibial insert sz 4-rt med 9mm, one (1) engage porous femoral sz 5-rt med and one (1) engage porous femoral sz 5-rt med were removed.

Manufacturer Narrative

The reported event was analyzed.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the engage porous tibial tray.Therefore, no investigation is deemed for the other devices.The device was not returned for evaluation.However, the photographs were reviewed, and revealed tissue residue and blood, however, there are no visible defects that can be associated with the reported adverse event.The clinical/medical investigation concluded that, based on the limited information provided, the clinical root cause of the reported pain is likely due to inadequate osseointegration of the tibia component; however, the root cause of the failed tibia component osseointegration cannot be definitively concluded.The patient impact is the reported pain, and the revision of the unicompartmental knee arthroplasty to total knee arthroplasty.The patient¿s current health status is unknown.A review of the production record did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for engage partial knee system revealed in adverse effects and complications that pain can result from improper positioning or loosening of the components.There is not enough data available to conclude that the overall clinical benefit outweighs the potential risk profile when compared to the state of the art.The existing data identifies a potential signal that the performance is an outlier vs the state of the art with respect to the risk for revision.In addition, a historical review concluded that no previous escalated actions for this type of issue were identified.However, as a correction action a voluntary market removal will be performed for the engage cementless partial knee system due recent complaint data that indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, lack of ingrowth, osteolysis and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: ENGAGE POROUS TIBIAL TRAY SZ 4-RT MED
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18359968
• MDR Text Key: 330933422
• Report Number: 1020279-2023-02528
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556873182
• UDI-Public: 885556873182
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1-10012-450
• Device Lot Number: 100267
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 1-10003-500/ENGAGE POROUS FEMORAL SZ 5-RT MED.; 1-10011-200/ENGAGE TIBIAL ANCHOR STEM SZ 3-4.; 1-10013-459/ENGAGE TIBIAL INSERT SZ 4-RT MED 9MM.
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 113 KG