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

Model Number	1-10003-510
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause of the event could not be determined from the information available.Manufacturer will continue to monitor for trends.
Event or Problem Description
Patient was complaining of knee pain at 5-months postop.5mo postop xrays did not indicate any device failure or malfunction but did present moderate joint space narrowing, far medial placement of femur, varus alignment and a lateral gap under tibial tray.2wks post op radiographs also presented similar misalignments.Revision was performed and converted to a total knee arthroplasty (another manufacturer's product) 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 drive; suite 206; orlando FL 32817
• Manufacturer Contact: dan justin ; 3505 lake lynda drive; suite 206; orlando, FL 32817 ; 8333642432
• MDR Report Key: 12246656
• Report Number: 3016249968-2021-00005
• Device Sequence Number: 4377703
• Product Code: NJD
• UDI-Device Identifier: B6951100035100
• UDI-Public: +B6951100035100/$$7100018R/14D20250507N
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K190439
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• 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): 07/29/2021

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: 05/07/2025
• Device Model Number: 1-10003-510
• Device Lot Number: 100018R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 07/29/2021
• 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: Reuse
• 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: ANCHOR STEM 5-6, 1-10011-300, LOT 100071.; INSERT LEFT SZ5 9MM 1-10013-509, LOT 100130.; TIBIAL TRAY LEFT SZ5, 1-10012-500, LOT 100045.; ANCHOR STEM 5-6, 1-10011-300, LOT 100071; INSERT LEFT SZ5 9MM 1-10013-509, LOT 100130; TIBIAL TRAY LEFT SZ5, 1-10012-500, LOT 100045
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male