MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENGAGE POROUS FEMORAL SZ 2-LT MED; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 1-10003-210

Device Problem Failure to Osseointegrate (1863)

Patient Problems Failure of Implant (1924); Pain (1994); Inadequate Osseointegration (2646)

Event Date 02/13/2023

Event Type  Injury  

Event Description

It was reported that, after a tka surgery had been performed on (b)(6) 2022, the patient experienced chronic pain.This adverse event was solved by a revision surgery on (b)(6) 2023, in which all the implants were exchanged with competitor devices.During the procedure the surgeon noticed that the femoral component had very little bone ingrowth.Tha patient outcome is unknown.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device did not reveal the stated failure mode.A lab analysis performed on the device revealed that the bone contacting surfaces of the femoral component have a degree of substance still adhered and scratching on the articulating surface likely due to removal.The articulating surface of the insert has signs of wear and deformation.The distal bone contacting surfaces of the tibial baseplate have a degree of substance still adhered and the tibial anchor is affixed to the baseplate.There were no observations of material or manufacturing deviations in the course of the investigation.The clinical/medical investigation concluded that, based on the images provided, the noted radiolucencies likely represent lack of bony ingrowth which could result in micromotion resulting in the reported chronic pain.The patient impact included the lack of bony ingrowth, pain, revision/conversion to a competitor total knee arthroplasty and was reported as ¿mechanical implant failure¿ with a 20-25 minute surgical extension due to repeat attempts to remove the tibial baseplate with the anchor removal tool.Further patient impact cannot not be determined although a transient rehabilitation phase would be anticipated.No further medical assessment can be rendered at this time.A review of the production order 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 warnings and precautions section that the success of the operation depends on the compliance with the operative technique supplied, and the proper use of the instrumentation supplied and specially designed for that range of implants.The surgeon should implant this system only in patients with sufficient intact soft tissue.Also, the risk factors section revealed that the following conditions, individually or together, will make fixation of the knee prosthesis challenging: advanced osteoporosis or insufficient bone stock, metabolic disorders or systemic medications leading to gradual loss of bone support for the prosthesis, history of disseminated systemic or local infection, significant deformations preventing correct fixation or placement of the prosthesis, tumors of the supporting bone structures, allergic reactions to the prosthesis materials or cement, tissue reaction to implant corrosion or wear debris and functional incapacity of the other joints.Besides, the adverse effects and complications section revealed that careful cleaning and correct preparation of the bone surfaces are essential for the fixation of the prosthesis, that bone resorption may damage the fixation or result in implant loosening and that pain has been identified as resulting from improper positioning, loosening or wear of the components.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that a similar event was identified due to a spike in the complaints where a revision surgery was performed.The following actions were performed: build robust sales training and medical education program for engage products, deliver training to active surgeon users and hold quarterly surgeon training events.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, size selected, lack of ingrowth, and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should 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.

Manufacturer Narrative

H3, h6: the associated devices were returned and evaluated.The visual inspection revealed scratches, deformation and some bone stuck on the devices.A lab analysis performed on the device revealed the bone contacting surfaces of the femoral component have a degree of substance still adhered and scratching on the articulating surface likely due to removal.The articulating surface of the insert has signs of wear and deformation.This distal bone contacting surfaces of the tibial baseplate have a degree of substance still adhered and the tibial anchor is affixed to the baseplate.There were no observations of material or manufacturing deviations in the course of this investigation.The clinical/medical investigation concluded that, based on the images provided, the noted radiolucencies likely represent lack of bony ingrowth which could result in micromotion resulting in the reported chronic pain.The patient impact included the lack of bony ingrowth, pain, revision/conversion to a competitor total knee arthroplasty and was reported as ¿mechanical implant failure¿ with a 20-25 minute surgical extension due to repeat attempts to remove the tibial baseplate with the anchor removal tool.Further patient impact cannot not be determined although a transient rehabilitation phase would be anticipated.No further medical assessment can be rendered at this time.A review of the production records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history based on the historical data revealed similar previous events, however, no commonalities that would suggest a device deficiency were found.A review of the instructions for use documents for engage partial knee system revealed in the warnings and precautions section that the success of the operation depends on the compliance with the operative technique supplied, and the proper use of the instrumentation supplied and specially designed for that range of implants.The surgeon should implant this system only in patients with sufficient intact soft tissue.Also, the risk factors section revealed that the following conditions, individually or together, will make fixation of the knee prosthesis challenging: advanced osteoporosis or insufficient bone stock, metabolic disorders or systemic medications leading to gradual loss of bone support for the prosthesis, history of disseminated systemic or local infection, significant deformations preventing correct fixation or placement of the prosthesis, tumors of the supporting bone structures, allergic reactions to the prosthesis materials or cement, tissue reaction to implant corrosion or wear debris and functional incapacity of the other joints.Besides, the adverse effects and complications section revealed that careful cleaning and correct preparation of the bone surfaces are essential for the fixation of the prosthesis, that bone resorption may damage the fixation or result in implant loosening and that pain has been identified as resulting from improper positioning, loosening or wear 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 and/or osteolysis.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: ENGAGE POROUS FEMORAL SZ 2-LT 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: 16527336
• MDR Text Key: 311128476
• Report Number: 1020279-2023-00491
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556872956
• UDI-Public: 885556872956
• 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,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1-10003-210
• Device Lot Number: 100015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1670-2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 78 KG