MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENGAGE TIBIAL INSERT SZ 6-LT MED 9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 1-10013-609

Device Problem Naturally Worn (2988)

Patient Problem Implant Pain (4561)

Event Date 05/01/2023

Event Type  Injury  

Manufacturer Narrative

Complaint reference number: (b)(4).

Event Description

It was reported that, after left partial knee replacement surgery had been performed on (b)(6) 2022, the patient experienced pain on the left knee.This adverse event was solved by revision surgery performed on (b)(6) 2023, in which all four (4) components were revised, and competitor device were implanted.The engage porous femoral sz 7-lt med had no visible bone ingrowth, the engage porous tibial tray sz 6-lt med had minimal bone ingrowth and the engage tibial insert sz 6-lt med 9mm had visible wear.Current health status of patient is unknown.

Manufacturer Narrative

H3, h6: the associated devices were returned and evaluated.The visual inspection revealed scratches, gouges and debris on the devices.The devices show signs of wear.A lab analysis performed on the devices revealed that the anchor stem is missing the tab.Some discoloration of the anchor stem can be seen.The tibial baseplate can be seen.A substance can be seen adhered to the bone contacting porous surface of the tibial baseplate.The femoral component can be seen.A substance can be seen adhered to the bone contacting porous surface of the femoral component.There were no observations of material or manufacturing deviations in the course of this investigation.The clinical/medical investigation concluded that, based on the limited information provided, the reported lack of bony ingrowth was most likely the contributing factor to the knee pain and insert wear; however, a definitive clinical root cause of the insufficient bone ingrowth cannot be concluded.Although field action was generated and a recall decision was made in order to mitigate future recurrence, it is unknown if patient comorbidities may have possibly contributed to the reported event.The patient impact included the reported pain and insert wear likely due to micromotion secondary to lack of bony integration along with the revision/conversion to competitor tka.Further patient impact cannot be determined.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 compliance with the operative technique supplied, and the proper use of the instrumentation supplied and specially designed for that range of implants.Additionally, incorrect fixation or positioning of the components, pain and excessive wear of the polyethylene component have been identified in the adverse effects and complications.Deformation or wear from one or more of the prosthetic components is often related to the risk factors detailed in the document.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 or patient condition.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: ENGAGE TIBIAL INSERT SZ 6-LT MED 9MM
• 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: 16992262
• MDR Text Key: 315839640
• Report Number: 1020279-2023-01117
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556874028
• UDI-Public: 885556874028
• 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
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1-10013-609
• Device Lot Number: 100410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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-1673-2023
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Male