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	Discomfort (2330); Deformity/ Disfigurement (2360)
Date of Event	01/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a right unicompartmental knee arthroplasty had been performed on (b)(6) 2021, the patient began experiencing some discomfort.Postoperative x-rays performed during follow up showed the tibia collapsed anteriorly into valgus with "blow-out" of medial tibial.The surgeon stated that the femoral component was placed more medially than desired due to pre-existing tibia vara deformity, leading to edge loading on the tibia.A revision surgery was performed on (b)(6) 2022 to treat this adverse event.During this procedure, the surgeon decided to remove all the elements from the prosthesis construct and replace them with a full tka system.The patient's outcome is unknown.
Additional Manufacturer Narrative
Section h3, h6: the device was not returned for evaluation but the provided imaging shows a pre-op tibial deformity, post-partial knee femoral component overhang, and a medial valgus collapse.The clinical/medical investigation concluded that, based on the information provided, the use of the components in a knee with a pre-op varus deformity is contraindicated.Additionally, the ifu addresses risks factors which may cause excessive loading and challenges within certain clinical contexts.Therefore, the surgeon¿s conclusion of contraindicated/patient selection, surgical technique issues with mal-positioning of femur (edge loading), and the abnormally high level of activity/post-op loading were most likely the contributing factors to the reported tibial collapse/fracture with malrotation of the tibial component.Of note, education/training actions are anticipated in order to mitigate similar events in the future.The patient impact beyond the reported discomfort, tibial collapse and subsequent revision/conversion to tka cannot be determined.No further clinical/medical assessment can be rendered at this time.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 uncontrolled varus/valgus has been identified as a postoperative adverse effect.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.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 contraindicated/patient selection, surgical technique issues with mal-positioning of femur (edge loading) and abnormally high level of activity/post-op.The contribution of the device to the reported event could be corroborated since a conversion to tka 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 clinical/medical investigation concluded that, the provided imaging supports the complaint showing a pre-op tibial deformity, post-partial knee femoral component overhang, and at 9 weeks, a medial valgus collapse resulting in fracture of the tibial bone.Based on the information provided, the use of the components in a knee with a pre-op varus deformity is contraindicated.Additionally, the instructions for use addresses risks factors which may cause excessive loading and challenges within certain clinical contexts.Therefore, the surgeon¿s conclusion of contraindicated/patient selection, surgical technique issues with mal-positioning of femur (edge loading), and the abnormally high level of activity/post-op loading were most likely the contributing factors to the reported tibial collapse/fracture with malrotation of the tibial component.Of note, education/training actions are anticipated in order to mitigate similar events in the future.The patient impact beyond the reported discomfort, tibial collapse and subsequent revision/conversion to total knee arthroplasty cannot be determined.No further clinical/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 contraindications that unicompartmental replacement is contraindicated in patients who have a permanent valgus or varus deformity that requires correction for the knee to function satisfactorily post-op.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 contraindicated/patient selection, surgical technique issues with mal-positioning of femur (edge loading), and the abnormally high level of activity/post-op loading.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: 14332826
• Report Number: 1020279-2022-02250
• Device Sequence Number: 5221361
• Product Code: NJD
• UDI-Device Identifier: 00885556873182
• UDI-Public: 885556873182
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/04/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2025
• Device Catalogue Number: 1-10012-450
• Device Lot Number: 100050
• 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: 06/17/2022; 06/30/2023
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 06/21/2022; 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2020
• 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: RES 92286
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TIBIAL ANCHOR STEM SIZE 3-4-100070; TIBIAL INSERT SIZE 4-RIGHT MED 9MM-100092
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 77 KG