MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 209999

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Joint Laxity (4526)

Event Date 06/08/2020

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

It was reported that the patient's left hip was revised due to instability. Surgeon reported his suspicion that the proximal cone body was probably not fully seated during the primary implantation. The proximal cone body, biolox ceramic head, and 36d 0° insert were revised to a proximal cone body, lfit v40 head, size d constrained insert, and a dall-miles grip plate with cables. Rep provided usage sheets for the primary and revision surgeries, pictures of the explants, and confirmed that no further information will be released.

• Brand Name: 3.0 RIO ROBOTIC ARM - MICS
• 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: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 10193058
• MDR Text Key: 197019291
• Report Number: 3005985723-2020-00221
• 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: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 209999
• Device Catalogue Number: 209999
• 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: 10/13/2020
• 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: 06/24/2020 Patient Sequence Number: 1