MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_RECON_ROBOTICS_PRODUCT; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number UNK_OFL

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Discomfort (2330); Irritability (2421)

Event Date 02/13/2017

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.

Event Description

The surgeon was completing a total knee arthroplasty procedure using the robotic arm interactive orthopedic system.1-2 weeks after the surgery, the patient experienced increasing erythema and fibrinous-type exudate from the anterior lower leg tracker pin site.The erythema was confined to 5-6cm around the pin site and has not streaked upwards towards the knee, with no signs the skin began the recovery healing process yet.On (b)(6) 2017, the patient specifically noticed an odor in the infected area, prompting the urgent care visit on (b)(6) 2017 to evaluate the drainage.Despite the drainage, the patient did not experience systemic symptoms with satisfying range of motion progress since the surgery.

Manufacturer Narrative

Reported event: the event reported the following: "the patient underwent a total knee replacement with the triathlon total knee system implanted in a mako robotic-arm assisted procedure on (b)(6) 2017 without any complications.1-2 weeks after the surgery, the patient experienced increasing erythema and fibrinous-type exudate from the anterior lower leg tracker pin site.The erythema was confined to 5-6 cm around the pin site and has not streaked upwards towards the knee, with no signs the skin began the recovery healing process yet.On (b)(6) 2017, the patient specifically noticed an odor in the infected area, prompting the urgent care visit on (b)(6) 2017 to evaluate the drainage.Despite the drainage, the patient did not experience systemic symptoms with satisfying range of motion progress since the surgery." device evaluation and results: unable to perform as the complaint was reported post-op and the part was not available.Device history review: unable to perform as information regarding the complaint product was not provided.Complaint history review: unable to perform as information regarding the complaint product was not provided.Conclusion: the complaint reported drainage and pain at the patient's lower leg at bone pin site.According the complaint details, the patient did not experience systemic symptoms with satisfying range of motion progress since the surgery despite the post-op drainage.If additional information becomes available, this investigation will be reopened.Corrective action / preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.The device was not returned to the manufacturer.

Event Description

The surgeon was completing a total knee arthroplasty procedure using the robotic arm interactive orthopedic system.1-2 weeks after the surgery, the patient experienced increasing erythema and fibrinous-type exudate from the anterior lower leg tracker pin site.The erythema was confined to 5-6 cm around the pin site and has not streaked upwards towards the knee, with no signs the skin began the recovery healing process yet.On (b)(6) 2017, the patient specifically noticed an odor in the infected area, prompting the urgent care visit on (b)(6) 2017 to evaluate the drainage.Despite the drainage, the patient did not experience systemic symptoms with satisfying range of motion progress since the surgery.

• Brand Name: UNKNOWN_RECON_ROBOTICS_PRODUCT
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• 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: michael mcavenia ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6339807
• MDR Text Key: 67704062
• Report Number: 3005985723-2017-00075
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_OFL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Other