MAUDE Adverse Event Report: SMITH & NEPHEW, INC. POROUS TIBIAL TRAY SIZE 3-RIGHT MEDIAL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR,

Catalog Number 1-10012-350

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/09/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a cementless unicompartmental right knee arthroplasty had been performed on (b)(6) 2021, the patient experienced a partial tibial fracture below the tibial tray as revealed by anteroposterior x-rays performed 6 weeks postoperatively.A revision surgery was conducted on (b)(6) 2022 to treat this adverse event.During this procedure, all the components from the uka prosthesis were explanted and replaced with an unspecified system.The patient's outcome is unknown.

Manufacturer Narrative

The device was not returned for evaluation but the pictures were reviewed and did not reveal any failure on the devices.However, the partial tibial fracture was confirmed.The clinical/medical investigation concluded that, the engage surgical ifu for the device, lists obesity or overweight of the patient as a risk factor that may cause excessive loading of the affected prosthesis, exposing the patient to greater risk of a partial knee arthroplasty failure.Therefore, the surgeon¿s conclusion of poor patient selection (the patient¿s extreme obesity) can be a contributory factor of the reported tibial fracture.The patient impact beyond the revision cannot be determined.No further clinical/medical assessment is warranted 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 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.A review of the instructions for use documents for engage partial knee system revealed that excessive physical activity, and operated limb traumas may cause early failure of the arthroplasty through implant displacement, fracture and/or wear has been identified as postoperative care.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.An historical review concluded that there are prior actions for the same device, but they cannot be linked to the complaint device.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or potential causes that could contribute to the reported event include excessive forces applied to implant, patient condition and surgical technique.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.

Manufacturer Narrative

The device was not returned for evaluation; therefore, a device analysis could not be performed.The photographs were reviewed and revealed that the device shows signs of use.The clinical/medical investigation concluded that, the engage surgical instructions for use for the device, lists obesity or overweight of the patient as a risk factor that may cause excessive loading of the affected prosthesis, exposing the patient to greater risk of a partial knee arthroplasty failure.Therefore, the surgeon¿s conclusion of poor patient selection (the patient¿s extreme obesity) can be a contributory factor of the reported tibial fracture.The patient impact beyond the revision cannot be determined.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 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 obesity or overweight is risk factor.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 surgeon patient selection and/ or patient condition.Based on this investigation, the need for corrective action may be indicated.

• Brand Name: POROUS TIBIAL TRAY SIZE 3-RIGHT MEDIAL
• Type of Device: 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: 14332927
• MDR Text Key: 291210062
• Report Number: 1020279-2022-02251
• Device Sequence Number: 1
• Product Code: NJD
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1-10012-350
• Device Lot Number: 100059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2020
• 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 AND Z-1672-202
• Patient Sequence Number: 1
• Treatment: POROUS FEMORAL COMP SIZE 5-RIGHT MEDIAL-100012.; TIBIAL ANCHOR STEM SIZE 3-4-100075.; TIBIAL INSERT SIZE 3-RIGHT MED 9MM-100086.
• Patient Outcome(s): Hospitalization; Other
• Patient Sex: Female