MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENGAGE POROUS TIBIAL TRAY SZ 5-LT MED; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR,

Catalog Number	1-10012-500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(6).This complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, after pka surgery had been performed on an unknown date, the patient experienced an engage porous tibial tray sz 5 lt med failure.This adverse event was treated by revision surgery on (b)(6) 2025, in which all components were removed and converted to a total knee arthroplasty.Current health status of patient is unknown.
Additional Manufacturer Narrative
Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the tibial component.The device was not returned for evaluation; therefore, a device analysis could not be performed.A visual inspection of the image provided was performed, and no damage was able to be detected.The devices shows signs of use.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 revision surgery has been identified in adverse effects and complications.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 as a correction action a voluntary market removal was 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.No details about the cause of the revision surgery were provided, therefore no factors that can contribute can be delineated.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: ENGAGE POROUS TIBIAL TRAY SZ 5-LT MED
• 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: 21543048
• Report Number: 1020279-2025-00435
• Device Sequence Number: 20600870
• Product Code: NJD
• UDI-Device Identifier: 00885556873199
• UDI-Public: 885556873199
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K190439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 05/23/2025

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: 06/11/2026
• Device Catalogue Number: 1-10012-500
• Device Lot Number: 100268
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2021
• 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: A
• 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: PN: 1-10011-300 / LOT: 100274; PN: 1-10013-511 / LOT: 100309
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown