MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TIBIAL INSERT SIZE 4-LEFT MED 10MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR,

Catalog Number 1-10013-410

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problems Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646); Joint Laxity (4526)

Event Date 02/28/2022

Event Type  Injury  

Event Description

It was reported that, after an uncemented unicompartmental left knee arthroplasty had been performed on (b)(6) 2021, the patient experienced joint instability, pain and discomfort.X-rays performed four (4) weeks postoperatively showed that the tibial tray was not fully seated upon implantation and that there was a gap posteriorly.The surgeon tried a bone stimulator on the patient to see if that would facilitate bone ingrowth.Additional x-rays performed eleven (11) months postoperatively showed pathologic radiolucent lines with non-uniform thickness under tray that were progressive in nature.A revision surgery was performed on (b)(6) 2022 to convert the knee into a full tka system.During this procedure, the surgeon noted that the femoral component had some ingrowth on the distal surface, but very little on the posterior surface with primarily fibrous ingrowth predominantly.Similarly, the tibial tray showed bone ingrowth near the anterior peg and medially under the anchor, with very little bone ingrowth on the posterior part of the tray.The tibial insert showed local deformation where the femur contacted the insert and had developed a groove.The patient's outcome is unknown.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after an uncemented unicompartmental left knee arthroplasty had been performed on (b)(6) 2021, the patient experienced joint instability, pain and discomfort.X-rays performed four (4) weeks postoperatively showed that the tibial tray was not fully seated upon implantation and, after seven (7) months of implantation, there was a gap posteriorly.The surgeon tried a bone stimulator on the patient to see if that would facilitate bone ingrowth.Additional x-rays performed eleven (11) months postoperatively showed pathologic radiolucent lines with non-uniform thickness under tray that were progressive in nature.A revision surgery was performed on (b)(6) 2022 to convert the knee into a full tka system.During this procedure, the surgeon noted that the femoral component had some ingrowth on the distal surface, but very little on the posterior surface with primarily fibrous ingrowth predominantly.Similarly, the tibial tray showed bone ingrowth near the anterior peg and medially under the anchor, with very little bone ingrowth on the posterior part of the tray.The tibial insert showed local deformation where the femur contacted the insert and had developed a groove.The patient's postoperative health status was reported as stable.

Manufacturer Narrative

The device was not returned for evaluation.A review of the photos of the explants did not confirm any failure of the device.However, the clinical/medical investigation concluded that, the radiolucent lines were present on lateral x-ray at 11 months with limited in-growth consistent with fibrous fixation and not bone in-growth.The implants were removed, with no damage evident to the implants.However, the implants were not returned for evaluations.Therefore, the clinical root cause of the reported failure could not be determined.Per the surgeon, we cannot rule out a surgical technique issue ¿ mal-positioned implants - tibial tray not initially seated posteriorly.In addition, we cannot rule out the lack of implant integration ¿ delayed integration due to the patient¿s initial activity level immediately following surgery.Reportedly, the patients will be non-weight bearing for two weeks and partial weight bearing for additional four-weeks (6 weeks total) to limit loading and help facilitate earlier in-growth.Since the patient¿s post-operative health status has been reported as stable, 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 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 risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the instructions for use revealed in the adverse effects and complications section that early loosening, tibial subsidence or wear of one or more of the prosthetic components, often related to risks factors such as overweight of the patient, hard physical labor, high level of activity or conditions as advanced osteoporosis or insufficient bone stock.Loosening can also occur as a result of an incorrect fixation or positioning of the components.Also pain resulting from improper positioning, loosening or wear of the components.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.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, traumatic injury and/or patient condition.The contribution of the device to the reported incident could be corroborated as a revision surgery was required to treat this event and the device was explanted.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.

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 clinical/medical investigation concluded that, based on the information provided, the radiolucent lines were present on lateral x-ray at 11months with limited in-growth consistent with fibrous fixation and not bone in-growth.The implants were removed, with no damage evident to the implants.However, the implants were not returned for evaluations.Therefore, the clinical root cause of the reported failure could not be determined.Per the surgeon, we cannot rule out a surgical technique issue ¿ mal-positioned implants - tibial tray not initially seated posteriorly.In addition, we cannot rule out the lack of implant integration ¿ delayed integration due to the patient¿s initial activity level immediately following surgery.Reportedly, the patients will be non-weight bearing for two weeks and partial weight bearing for additional four-weeks (6 weeks total) to limit loading and help facilitate earlier in-growth.Since the patient¿s post-operative health status has been reported as stable, 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 for the part and batch number of the device did not reveal similar previous events for the listed device.A review of the instructions for use documents for engage partial knee system revealed in the adverse effects and complications section that early loosening, tibial subsidence, bending, fissure fracture, fracture, deformation or wear of one of more of the prosthetic components, often related to such as overweight of the patient, hard physical labor, high level of activity or conditions as advanced osteoporosis or insufficient bone stock.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 friction or joint tightness.Based on this investigation, the need for corrective action is not indicated.Based on this investigation, the need for corrective action may be indicated.

• Brand Name: TIBIAL INSERT SIZE 4-LEFT MED 10MM
• 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: 14333350
• MDR Text Key: 291204325
• Report Number: 1020279-2022-02256
• Device Sequence Number: 1
• Product Code: NJD
• UDI-Device Identifier: 00885556873489
• UDI-Public: 885556873489
• 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,Followup
• Report Date: 07/11/2023

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: 1-10013-410
• Device Lot Number: 100126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2020
• 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
• Patient Sequence Number: 1
• Treatment: TIBIAL ANCHOR STEM SIZE 3-4-100070
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 65 KG