MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENGAGE POROUS FEMORAL SZ 3-RT MED; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 1-10003-300

Device Problem Loss of Osseointegration (2408)

Patient Problem Insufficient Information (4580)

Event Date 04/13/2023

Event Type  Injury  

Event Description

It was reported that after a tka surgery was performed on (b)(6) 2021, a revision surgery had to be performed on (b)(6) 2023 in order to remove engage implants as they were not well fixed.No further details available at this moment.No further information is available.

Manufacturer Narrative

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

Manufacturer Narrative

The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided for evaluation.It has been communicated via e-mail that further information is unknown.Therefore, there were no clinical factors found which would have contributed to the reported event.Per case details, the surgeon doesn't think i is product failure.The patient impact beyond the revision surgery could not be determined.No further clinical 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 has been identified in the adverse effects and complications and can result in loosening of the implants.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 products 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, loss of ingrowth, osteolysis and/or traumatic injury.Based on this investigation, the need for corrective action may be indicated.

• Brand Name: ENGAGE POROUS FEMORAL SZ 3-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: 16883070
• MDR Text Key: 314710010
• Report Number: 1020279-2023-00994
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556872963
• UDI-Public: 885556872963
• 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: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2023
• Device Catalogue Number: 1-10003-300
• Device Lot Number: 100178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2023
• Date Device Manufactured: 03/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: RES 92286
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention