MAUDE Adverse Event Report: SMITH & NEPHEW, INC. POROUS TIBIAL TRAY SIZE 4-RIGHT MEDIAL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR,

Catalog Number	1-10012-450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthralgia (2355); Deformity/ Disfigurement (2360)
Date of Event	01/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after an uncemented right knee unicompartmental arthroplasty had been performed on (b)(6) 2021, the patient start experiencing pain when walking.Postoperative radiographic imaging appear to show a malposition of the tibial tray and a medialized femoral component resulting in edge loading of tibial tray.A revision surgery was performed on (b)(6) 2022 to treat this adverse event.During this procedure, the tibial tray was explanted and replaced with a new cemented size 4 tibial tray and the tibial insert was upsized from a 9mm to a 11mm.The patient's outcome and current health status is unknown.
Additional Manufacturer Narrative
H3, h6.The device was not returned for evaluation but the pictures were reviewed and did not reveal any failure on the devices.However, the mal-position of the implants was confirmed.The clinical/medical investigation concluded that, based on the information provided, the revision was performed due to the malposition of the femur and the reported edge-loading in addition to, a procedure variance-varus tibial cut.The implants were removed successfully.The impact to the patient beyond the revision of the tibial component, which has already reported cannot be determined.Should any additional relevant medical information be provided, this case would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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, dislocation, subluxation, flexion contracture, mobility reduction, leg shortening or lengthening, resulting from improper positioning of the components has been identified in adverse effects and complications.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 there are prior actions related to this product and event: corrective and preventive actions are being performed to reduce the risk of a revision surgery from happening.Assessment of historical escalated cases concluded that a similar event was identified and determined that the primary root cause for revision surgeries 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.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance.The contribution of the device to the reported event could be corroborated since a revision surgery was required.Based on this investigation, the need for corrective action is not indicated.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; therefore, a device analysis could not be performed.The photographs were reviewed, and did not confirm any failure of the device.The device shows signs of use.The clinical/medical investigation concluded that, the provided analysis of the x-rays provided revealed a mal-position of implants.Based on the information provided, the revision was performed due to the malposition of the femur and the reported edge-loading in addition to, a procedure variance-varus tibial cut.The implants were removed successfully.The impact to the patient beyond the revision of the tibial component, which has already reported cannot be determined.Should any additional relevant medical information be provided, this case would be re-assessed.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, dislocation, subluxation, flexion contracture, mobility reduction, leg shortening or lengthening, resulting from improper positioning of the components, have 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 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.

• Brand Name: POROUS TIBIAL TRAY SIZE 4-RIGHT MEDIAL
• 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: 14332691
• Report Number: 1020279-2022-02247
• Device Sequence Number: 5199061
• Product Code: NJD
• UDI-Device Identifier: 00885556873182
• UDI-Public: 885556873182
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,User Facility,Company Representative
• 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: 05/07/2025
• Device Catalogue Number: 1-10012-450
• Device Lot Number: 100060
• 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: 04/10/2022
• Supplement Date Received by Manufacturer: 06/23/2022; 06/23/2023
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 06/24/2022; 06/26/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1672-2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: POROUS FEMORAL COMP SIZE 4-RIGHT MEDIAL-100179; TIBIAL ANCHOR STEM SIZE 3-4-100073; TIBIAL INSERT SIZE 4-RIGHT MED 9MM-100092
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 61 YR
• Patient Sex: Male