MAUDE Adverse Event Report: SMITH & NEPHEW, INC. POROUS FEMORAL COMP SIZE 3-LEFT MEDIAL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	1-10003-310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a uka surgery performed on (b)(6) 2021, where a porous coated femoral comp, size 3-left medial, a porous tibial tray size 2-left medial and a tibial insert size 2-left med 9mm were implanted.The patient underwent a revision surgery on (b)(6) 2022 to exchange the system for a tka.Current health status of the patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.The pictures provided were reviewed and did not reveal any functional issue with the device.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The attached pics of the implants and the implant record were provided and reviewed; however, they did not contribute to determining the root cause.The impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Therefore, no further clinical/medical assessment is warranted at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.A review of the instructions for use documents for engage® partial knee system revealed in the postoperative care section that patients should be caution to control their level of activity and avoid excessive loads on the replaced joint, and make them aware of the precautions to be taken with regards to exercise, treatments and limitations on activities, as well as avoiding exposure to magnetic fields.Periodic follow-up and x-rays are recommended to make comparisons with the immediate postoperative condition and identify implant displacement or loosening.Excessive physical activity, and operated limb traumas may cause early failure of the arthroplasty through implant displacement, fracture and/or wear.If the case occurs, it is necessary to place the patient under supervision, evaluate the possible progression of the deterioration, and weigh the benefit of early revision.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.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 product failed to meet any product specifications at the time of manufacture.No details of the alleged fault, malfunction or injury were provided, therefore no factors that can contribute can be delineated.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device 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
The device was not returned for evaluation.The pictures provided were reviewed and did not reveal any functional issue with the device.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The attached pics of the implants and the implant record were provided and reviewed; however, they did not contribute to determining the root cause.The impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Therefore, no further clinical/medical assessment is warranted 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 for the part number and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for engage partial knee system revealed in the postoperative care section that patients should be caution to control their level of activity and avoid excessive loads on the replaced joint, and make them aware of the precautions to be taken with regards to exercise, treatments and limitations on activities, as well as avoiding exposure to magnetic fields.Periodic follow-up and x-rays are recommended to make comparisons with the immediate postoperative condition and identify implant displacement or loosening.Excessive physical activity, and operated limb traumas may cause early failure of the arthroplasty through implant displacement, fracture and/or wear.If the case occurs, it is necessary to place the patient under supervision, evaluate the possible progression of the deterioration, and weigh the benefit of early revision.A review of the risk management file revealed this failure mode was previously identified.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 product specifications at the time of manufacture.No details of the alleged fault, malfunction or injury were provided, therefore no factors that can contribute can be delineated.Based on this investigation, the need for corrective action may be indicated.

• Brand Name: POROUS FEMORAL COMP SIZE 3-LEFT MEDIAL
• Common Device Name: 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: 15546897
• Report Number: 1020279-2022-04333
• Device Sequence Number: 11242537
• Product Code: HSX
• UDI-Device Identifier: 00885556872970
• UDI-Public: 885556872970
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K190439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2023

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: 01/05/2026
• Device Catalogue Number: 1-10003-310
• Device Lot Number: 100184
• 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: 09/15/2022
• Supplement Date Received by Manufacturer: 11/03/2022; 06/23/2023
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 11/07/2022; 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2021
• 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: A
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 92286
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female