MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENGAGE POROUS FEMORAL SZ 5-RT MED; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR,

Catalog Number	1-10003-500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery was performed on (b)(6) 2022, the patient experienced pain for a long duration of time.This adverse event was treated by a revision surgery on (b)(6) 2022, in which a engage porous femoral sz 5-rt med, porous tibial tray size 6-right medial, engage tibial insert sz 6-rt med 9mm and engage tibial anchor stem sz 5-6 were removed.Patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The photograph was reviewed but did not reveal any defects that would cause the stated adverse event.The clinical/medical investigation concluded that, the provided photo was reviewed; however, it does not aid in the clinical investigation of the root cause of the reported pain.As of the date of this medical investigation, the requested clinical documentation has not been provided for evaluation.Therefore, there were no clinical factors found which would have contributed to the reported event.The patient's current condition is unknown and the patient impact beyond the revision surgery could not be determined.No further clinical assessment can be rendered at this time.For engage porous femoral sz 5-rt med , engage tibial insert sz 6-rt med 9mm , engage tibial anchor stem sz 5-6 , a review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For porous tibial tray size 6-right medial, device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.For engage porous femoral sz 5-rt med, a review of complaint history based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.For porous tibial tray size 6-right medial, a review of complaint history for the previous 12 months did not reveal similar events for the listed device.For engage tibial insert sz 6-rt med 9mm, 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.For engage tibial anchor stem sz 5-6, a review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for engage partial knee system revealed that pain has been identified in adverse effects and complications.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that this event was previously identified and addressed through the following actions: a historical review concluded that a similar event was identified due to a spike in the complaints where a revision surgery was performed and determined that the primary root cause is: insufficient surgeon and medical education training program.Furthermore, there were limited resources available to engage to complete a more detailed surgeon training program.The following actions will be 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 products failed to meet any product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.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.Should the devices or 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.
Additional Manufacturer Narrative
Additional information: h7, h10.H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The photograph was reviewed but did not reveal any defects that would cause the stated adverse event.The clinical/medical investigation concluded that, the provided photo was reviewed; however, it does not aid in the clinical investigation of the root cause of the reported pain.As of the date of this medical investigation, the requested clinical documentation has not been provided for evaluation.Therefore, there were no clinical factors found which would have contributed to the reported event.The patient's current condition is unknown and the patient impact beyond the revision surgery could not be determined.No further clinical assessment can be rendered at this time.For engage porous femoral sz 5-rt med , engage tibial insert sz 6-rt med 9mm , engage tibial anchor stem sz 5-6, a review of the production records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For porous tibial tray size 6-right medial, device batch number was not provided, thus, an evaluation of the production records could not be performed.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 has been identified in adverse effects and complications.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 product 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.H6 (investigation findings).

• Brand Name: ENGAGE POROUS FEMORAL SZ 5-RT MED
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR,
• 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: 16089355
• Report Number: 1020279-2023-00008
• Device Sequence Number: 2034250
• Product Code: NJD
• UDI-Device Identifier: 00885556873007
• UDI-Public: 885556873007
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K190439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Catalogue Number: 1-10003-500
• Device Lot Number: 100012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 02/17/2023; 07/06/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 02/20/2023; 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1-10011-300 / LOT 100274; 1-10012-650 / LOT 10034; 1-10013-659 / LOT 100362
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown