MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENGAGE POROUS FEMORAL SZ 7-LT MED; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 1-10003-710

Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Pain (1994)

Event Date 08/14/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, after a tka had been performed on (b)(6) 2022, the patient experienced extreme pain, infection, loosening and mechanical failure.A revision surgery was was performed on (b)(6) 2023 to address this adverse event.The following four implants were explanted: engage porous femoral sz 7-lt med, engage tibial insert sz 6-lt med 9mm, engage porous tibial tray sz 6-lt med and engage tibial anchor stem sz 5-6.

Manufacturer Narrative

H3, h6: the associated devices were returned and evaluated.The visual inspection revealed discoloration and foreign debris on the device.The visual also reveals the insert is heavily gouged.The tibial tray and anchor reveals signs of significant wear.A lab analysis performed on the devices to determine the cause of the reported incident.No destructive analysis was conducted during this investigation.Substance is still adhered to the bone contacting porous surface of the femoral component and the articulating surface is scratched.The articulating surface of the insert is worn with some discoloration.The locking detail on the insert is damaged.The tibial baseplate component is worn on all sides and has substance still adhered to the bone contacting porous surface.The anchor is still mated to the tibial 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 information provided, the clinical root cause of the reported unspecified infection, loosening and mechanical failure cannot be definitively concluded.The clinical root cause of the pain is likely related to the infection and loosening.However, it is well known that infection can lead to implant loosening, implant failure, fixation issues, and the reported infection cannot be ruled out as a contributing factor to the reported loosening, pain and ¿mechanical failure.¿ additionally, it is unknown if the unspecified infection is hematogenous in nature and no bacterial cultures or other serum lab reports were provided for review.The operative report was also not provided.The patient impact beyond the reported the pain, unspecified infection, loosening, ¿mechanical failure,¿ and subsequent revision cannot be determined.The patient¿s current health status is unknown.Therefore, no further medical assessment can be rendered.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the femoral, tibial tray, insert and stem, 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 adverse effects and complications revealed that early or late loosening are related with risk factors.Loosening can also occur as a result of an incorrect fixation or positioning of the components.Early or late infection may require removal of the implant followed arthrodesis or 2-stage reimplantation.Pain and mobility reductions can result 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.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.A review of the sterilization records revealed the batches were sterilized within normal parameters.Factors that could contribute to the reported event include traumatic injury, joint tightness, abnormal motion over time, bone degeneration, loss of ingrowth, osteolysis, patient condition and/or medical history.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action may be indicated.

• Brand Name: ENGAGE POROUS FEMORAL SZ 7-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: 17686763
• MDR Text Key: 322695684
• Report Number: 1020279-2023-01721
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556873052
• UDI-Public: 885556873052
• 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
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

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: 1-10003-710
• Device Lot Number: 100188-X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 01/02/2024
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• 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: ENGAGE POROUS TIBIAL TRAY SZ 6-LT MED, LOT#:100270; ENGAGE TIBIAL ANCHOR STEM SZ 5-6, LOT#:100274; ENGAGE TIBIAL INSERT SZ 6-LT MED 9MM, LOT#:100315
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male