MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENGAGE TIBIAL ANCHOR STEM SZ 5-6; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	1-10011-300
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a tka revision surgery, the engage tibial anchor stem sz 5-6 was difficult to disengage.The window in the anchor could not be freed of bone for the hook to latch onto.After multiple efforts to remove the anchor, a bone tamp was used to lift the tibial base plate off with the anchor still intact.No augments were needed on the tibial, a 12mm poly was used to make up for the heavy tibia cut due to the deficit from the anchor.The procedure was resumed, after a non-significant delay, with a competitor device.No further complications were reported.
Additional Manufacturer Narrative
H3.H6: the associated devices were returned and evaluated.The visual inspection revealed the anchor stem is stuck to the tibial baseplate.A lab analysis performed on the device revealed the anchor is still mated to the tibial baseplate.There were no observations of material or manufacturing deviations in the course of this investigation.The clinical/medical investigation concluded that, based on the information provided, the clinical root cause of the reported ¿the engage tibial anchor stem sz 5-6 was difficult to disengage¿ cannot be definitively concluded.The operative report for the primary surgery (partial knee arthroplasty) was not provided for review.Reportedly, ¿no augments were needed on the tibial, a 12mm poly was used to make up for the heavy tibia cut due to the deficit from the anchor.¿ the patient impact beyond the reported (¿the engage tibial anchor stem sz 5-6 was difficult to disengage¿) cannot be determined.The procedure was resumed, after a non-significant delay, and ¿no further complications were reported.¿ the patient¿s current health status is unknown.Therefore, no further medical assessment can be rendered.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the anchor and the tibial tray, 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 the surgical technique section that the surgeon should be fully familiar with the surgical technique.Supplementary information about the surgical techniques and products are available on request.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.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 products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include user/procedural variance and/or insertion and extraction technique.Based on this investigation, the need for corrective action may be indicated.

• Brand Name: ENGAGE TIBIAL ANCHOR STEM SZ 5-6
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 17684933
• Report Number: 1020279-2023-01723
• Device Sequence Number: 6179731
• Product Code: HSX
• UDI-Device Identifier: 00885556873106
• UDI-Public: 885556873106
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K190439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

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: 06/08/2026
• Device Catalogue Number: 1-10011-300
• Device Lot Number: 100274
• 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: 08/14/2023
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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-1671-2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN:1-10012-600, LN:100270,ENGAGE POROUS TIBIAL TRA
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown