MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_MAKO_ROBOT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number UNK_OFL

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.Device not returned.

Event Description

It was reported, "on (b)(6) 2020, patient (b)(6) (years old) had a surgical operation on her knee at the best private hospital of the country, applying your technology (robotics).After about 60 physiotherapist sessions, doctor's assistance and the lapse of a 10- month period, still have problems, as, the knee continues to swell after a walk of each day.A permanent difficulty exists in standing up and walk, when either getting-up from bed or from a chair after sitting for over 15 minutes.After the every day exercise in walking over a mile, there is tightening and fatigue on the knee.Straight alignment of the knee was never restored.Almost every day the patient takes painkillers to make it through the day.This disappointment led us to pay a visit to another orthopedic dr whose comments are: the most common surgery applied on patients at the age of 70-years-old + is a full repair of the knee and not half as it was done in our case, and something might be wrong or not a perfect fit.Recently there is pain on both sides of the leg (tibia and calf) every day after standing or walking.".

Event Description

It was reported, "on (b)(6) 2020, patient (70 years old) had a surgical operation on her knee at the best private hospital of the country, applying your technology (robotics).After about 60 physiotherapist sessions, doctor's assistance and the lapse of a 10- month period, still have problems, as, 1) the knee continues to swell after a walk of each day.2) a permanent difficulty exists in standing up and walk, when either getting-up from bed or from a chair after sitting for over 15 minutes.3) after the every day exercise in walking over a mile, there is tightening and fatigue on the knee.4) straight alignment of the knee was never restored.5) almost every day the patient takes painkillers to make it through the day.6) this disappointment led us to pay a visit to another orthopedic dr whose comments are: a) the most common surgery applied on patients at the age of 70- years-old + is a full repair of the knee and not half as it was done in our case, and b) something might be wrong or not a perfect fit.7) recently there is pain on both sides of the leg (tibia and calf) every day after standing or walking.".

Manufacturer Narrative

Reported event: an event regarding pain involving an unknown pka software was reported.The event was not confirmed.Method & results: -product evaluation and results: a review of the information provided from the filed noted the following: there was no session file included however the bone registration, presurgical check point, and interoperative planning of the femur are available.This investigation is inconclusive as factors such as infection, robot errors, workflow, and other factors such as final implant position cannot be determined from the evidence provided.However, the bone registration pattern used on the femur is the most probable cause for the potential implant positional pain, which the patient seems to be experiencing.This is not a failure of the mako system, but a failure of the surgeon to follow the recommended registration pattern.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a review of device history records could not be completed as the device was not properly identified.-complaint history review: a review of complaints could not be completed as the device was not properly identified.Conclusions: the alleged failure of the patient experiencing pain was not confirmed as insufficient information was provided, however, based on a review of the provided system it was determined that the surgeon did not follow the recommended registration pattern and this is the probable cause of the patient experiencing pain.Further information such as pre- and post-operative x-rays, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.The data at this time shows that no system defect or malfunction is suspected.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

• Brand Name: UNKNOWN_MAKO_ROBOT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12032360
• MDR Text Key: 261252705
• Report Number: 3005985723-2021-00108
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: GR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/27/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_OFL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/21/2021
• Supplement Dates Manufacturer Received: 05/17/2022
• Supplement Dates FDA Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female