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

Model Number 219999

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 08/19/2020

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.

Event Description

This pi is for the closed reduction on (b)(6) 2020. As reported: "pt discharged to inpatient rehab (b)(6) 2020. On (b)(6) 2020 pt out of bed unassisted, bent over to pick something up off floor and felt sharp pain in hip. Xray showed dislocation, pt taken to or for closed reduction. Pt discharged home (b)(6) 2020. On (b)(6) 2020 pt presented to emergency department with complaint of hip pain & swelling - pt admitted w/ cellulitis. Pt to operating room (b)(6) 2020 for i&d - positive wound culture - deep surgical site infection. Pt left against medical advice post-op. ".

• 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: daniela davila ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 11118053
• MDR Text Key: 225155937
• Report Number: 3005985723-2021-00006
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 219999
• Device Catalogue Number: 219999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: No
• 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: 01/05/2021 Patient Sequence Number: 1