MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TIBIAL ANCHOR STEM SIZE 1-2; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR,

Catalog Number	1-10011-100
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Failure of Implant (1924); Arthralgia (2355)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a cementless unicompartmental left knee arthroplasty had been performed on (b)(6) 2021, the patient start experiencing pain at the knee.Lateral x-rays performed two (2) months postoperatively appear to demonstrate a mal-positioned tibial tray.Lateral x-rays performed five and half (5.5) months postoperatively revealed a tibial tray subsidence and the partial fracture of the anchor component.A revision surgery was performed on (b)(6) 2022 to treat this adverse event.During this procedure, all the uka components were explanted and replaced with a full tka system.The patient's outcome is unknown.
Additional Manufacturer Narrative
The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the engage surgical ifu for the device, lists obesity or overweight of the patient and high level of activity, individually or together, 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 and the mal-positioned implant as well as the ¿lots of hiking¿ as reported by the patient are likely contributing factors to the fracture of the tibial anchor and subsidence of the tibial tray.It cannot be concluded that the reported events are associated with a malperformance of the implant.The patient impact beyond the pain and subsequent 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 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 that periodic follow-up and x-rays are recommended to make comparisons with the immediate postoperative condition and identify implant displacement, loosening, etc.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 have 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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Assessment of historical escalated cases concluded that a similar event was identified 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.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.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; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the engage surgical instructions for use for the device, lists obesity or overweight of the patient and high level of activity, individually or together, 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 and the mal-positioned implant as well as the ¿lots of hiking¿ as reported by the patient are likely contributing factors to the fracture of the tibial anchor and subsidence of the tibial tray.It cannot be concluded that the reported events are associated with a malperformance of the implant.The patient impact beyond the pain and subsequent 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 for the part number and for the batch number based on historical data 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 periodic follow-up and x-rays are recommended to make comparisons with the immediate postoperative condition and identify implant displacement, loosening, etc.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.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, post operative care and/ or patient condition.Based on this investigation, the need for corrective action may be indicated.

• Brand Name: TIBIAL ANCHOR STEM SIZE 1-2
• 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: 14333089
• Report Number: 1020279-2022-02253
• Device Sequence Number: 5236884
• Product Code: NJD
• UDI-Device Identifier: 00885556873083
• UDI-Public: 885556873083
• Combination Product (Y/N): N
• 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: 1-10011-100
• Device Lot Number: 100069
• 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: 06/10/2022; 06/30/2023
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 06/15/2022; 07/05/2023
• 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: POROUS FEMORAL COMP SIZE 2-LEFT MEDIAL-100001; TIBIAL INSERT SIZE 2-LEFT MED 9MM-100113
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 93 KG