MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO UKR X3 ONLAY INSERT SIZE 3 - 8 MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Model Number 180733-1-E

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding infection involving a mako insert was reported.The event was not confirmed.View wit the following devices were also listed in this report: 209999; 3.0 rio¿ robotic arm - mics; rob119.Unknown_mako pka baseplate.Unknown_mako pka femoral component.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

It was reported that a poly swap was performed on the patient's left knee due to infection.Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: MAKO UKR X3 ONLAY INSERT SIZE 3 - 8 MM
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: joanne mahony ; ida industrial estate; carrigtwohill NA ; EI NA ; 214532800
• MDR Report Key: 11553245
• MDR Text Key: 241750136
• Report Number: 3005985723-2021-00053
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 07613327385892
• UDI-Public: 07613327385892
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 180733-1-E
• Device Catalogue Number: 180733-1-E
• Device Lot Number: D341H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR