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

Catalog Number 1-10003-400

Device Problem Failure to Osseointegrate (1863)

Patient Problems Arthralgia (2355); Inadequate Osseointegration (2646)

Event Date 03/20/2023

Event Type  Injury  

Event Description

It was reported that after an ukr surgery was performed in june of 2022 using an engage system, the patient had persistent pain.A revision surgery was performed on (b)(6) 2023, on which the engage porous femoral sz 4-rt med device was found to be relatively loose with just fibrous on-growth.Current health status of patient is unknown.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H10: additional information in d9.H11: corrected information in d4 (lot # and exp date) and h4.

Manufacturer Narrative

Additional information: d10.H3, h6: the associated devices were returned and evaluated.The visual inspection revealed gouges and scratches on the devices.The devices show signs of wear.The clinical/medical investigation concluded that, as of the date of this medical investigation, the supporting clinical documentation has not been provided.A loosened femoral component was reportedly found during the revision; therefore, cannot be ruled out as the contributing factor to the revision; however, a definitive clinical root cause of the lack of bony on-growth cannot be concluded.The patient impact beyond the reported pain, loosened component and subsequent revision cannot be determined.No further medical assessment could 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 that that pain can result from improper positioning, loosening or wear of components.Besides, loosening can occur as a result of an incorrect fixation or positioning 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 traumatic injury, joint tightness, patient condition or postoperative care.Based on this investigation, the need for corrective action may be indicated.

Manufacturer Narrative

The associated device was returned and evaluated.The visual inspection revealed gouges and scratches on the devices.The devices show signs of wear.A lab analysis performed on the devices revealed that the femoral component, insert, and tibial baseplate are all worn.The porous bone contacting surfaces of the femoral and tibial baseplate components still have substance adhered to them.The anchor stem is damaged and still connected 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, as of the date of this medical investigation, the supporting clinical documentation has not been provided.A loosened femoral component was reportedly found during the revision; therefore, cannot be ruled out as the contributing factor to the revision; however, a definitive clinical root cause of the lack of bony on-growth cannot be concluded.The patient impact beyond the reported pain, loosened component and subsequent revision cannot be determined.No further medical assessment could 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 that pain can result from improper positioning, loosening or wear of components.Besides, loosening can occur as a result of an incorrect fixation or positioning 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 traumatic injury, joint tightness, patient condition or postoperative care.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: ENGAGE POROUS FEMORAL 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: 16735882
• MDR Text Key: 313251312
• Report Number: 1020279-2023-00824
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556872987
• UDI-Public: 885556872987
• 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,Followup
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1-10003-400
• Device Lot Number: 100225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2021
• 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
• Treatment: 1-10011-300/ENGAGE TIBIAL ANCHOR STEM SZ 5-6; 1-10012-550/ENGAGE POROUS TIBIAL TRAY SZ 5-RT MED; 1-10013-559/ENGAGE TIBIAL INSERT SZ 5-RT MED 9MM
• Patient Outcome(s): Required Intervention