MAUDE Adverse Event Report: ENGAGE UNI, LLC (DBA ENGAGE SURGICAL) ENGAGE SURGICAL PARTIAL KNEE SYSTEM; UNICOMPARTMENTAL KNEE ARTHROPLASTY (UKA)

Model Number	1-10012-250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was returned to engage surgical for evaluation; there was no damage or structural issues with any of the implants.Investigation into the patient demographic information revealed: sex - female, height - 60" (5 ft), weight - (b)(6) lbs, bmi - 39 (obese), other - chronic smoker.Obesity and smoking are identified as risk factors per the product instructions for use (ifu): "the following conditions, individually or together, may cause excessive loading of the affected prosthesis, exposing the patient to greater risk of a partial knee arthroplasty failure: obesity or overweight of the patient and smoking." given the multiple risk factors presented, it was determined that patient selection is the most probable cause of the tibial subsidence.Revisions of partial knee arthroplasty (also known as uka) among obese females are well-documented in clinical literature.
Event or Problem Description
It was reported that a patient was complaining of anterior knee pain after four weeks post-op.The surgeon reviewed her x-rays and determined that the patient experienced anteromedial tibial subsidence.The surgeon provided two options to patient; 1) non-weight bearing for a few weeks to let the bone heal, or 2) revise from partial knee arthroplasty to total knee arthroplasty (tka).The patient elected to have a revision procedure.The procedure was performed without any further issues.
Additional Manufacturer Narrative
Investigation update: as 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.Based on this investigation, the need for corrective action may be indicated.

• Brand Name: ENGAGE SURGICAL PARTIAL KNEE SYSTEM
• Common Device Name: UNICOMPARTMENTAL KNEE ARTHROPLASTY (UKA)
• Manufacturer (Section D): ENGAGE UNI, LLC (DBA ENGAGE SURGICAL); 3505 lake lynda dr; suite 206; orlando FL 32817
• Manufacturer Contact: teresa cherry ; 3505 lake lynda dr; suite 206; orlando, FL 32817 ; 8333642432
• MDR Report Key: 11579367
• Report Number: 3016249968-2021-00002
• Device Sequence Number: 3599568
• Product Code: NJD
• UDI-Device Identifier: B6951100122500
• UDI-Public: +B6951100122500/$$7100048/14D202503090
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: 03/09/2025
• Device Model Number: 1-10012-250
• Device Lot Number: 100048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 03/27/2021
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 91 KG