MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO ROBOTIC ARM 3.1 ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 219999

Device Problems Fracture (1260); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/23/2021

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

It was reported by sale rep that there was an accident in mako tka case at (b)(6) ((b)(6) 2021 ) which surgeons of this case found some fracture of posterior condyle of femur after done in every step of bone cut affected to femur prosthesis which can not place in there. It may be occurred from soft bone or too big housing cutting block for size 2 of femur prosthesis. So they ask for constrain prosthesis with stem to use replaced but we haven't prepare with this case because this is primary case. However surgeons ask for support from zimmer company and the operation was completely done. Surgical delay 2 hours.

• Brand Name: MAKO ROBOTIC ARM 3.1
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, FL WD6 3-SJ ; UK WD6 3SJ ; 9546280700
• MDR Report Key: 12193004
• MDR Text Key: 262462448
• Report Number: 3005985723-2021-00132
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K142530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 219999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/22/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 07/19/2021 Patient Sequence Number: 1