MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_MAKO ROBOTIC ARM ASSISTED UKA; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number UNK_OFL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 02/29/2024

Event Type  Injury  

Event Description

A draft manuscript titled "safety and feasibility of outpatient mako robotic uka versus conventional tka" was received.In it, table 4 indicates that 7 mako partial knees were revised.Per the article: revision procedures were classified as: revision ukas, conversion to tkas, quadriceps tendon repairs, and arthroscopic debridements/ lysis of adhesions.

Manufacturer Narrative

Reported event: an event regarding revision involving an unknown mako knee was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: no medical records were received for review with a clinical consultant.-product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.H3 other text : device not available.

• Brand Name: UNKNOWN_MAKO ROBOTIC ARM ASSISTED UKA
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: kelsey williams ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18990023
• MDR Text Key: 338767579
• Report Number: 3005985723-2024-00037
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_OFL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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