MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209999

Device Problems Computer Software Problem (1112); Non Reproducible Results (4029)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 08/23/2019

Event Type  Injury  

Manufacturer Narrative

As part of the 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 robot used in the primary procedure.It was reported that the patient's left knee was revised after patient complaint of pain.Revision surgery took place with no stryker rep present.It is unknown if there are any intra-operative findings.A size 6 cr femur, 6x11 cs insert, size 6 baseplate, and an a32 x3 asymmetric all-poly patellar component (implanted using the mako robot in (b)(6) 2018) were revised.Rep has supplied the primary operative report and pre-revision x-rays.

Manufacturer Narrative

Reported event: an event regarding revision involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: review of the device history records associated with rio 502 indicate quality inspection procedures were completed with no reported discrepancies.Complaint history: a search of the complaint database under device identification pn (b)(4) reports similar complaints for tka software - revision.The complaint record numbers are: (b)(4).Conclusion: not performed as case session data was not provided.H3 other text : product was not available for evaluation.

Event Description

This pi is for the robot used in the primary procedure.It was reported that the patient's left knee was revised after patient complaint of pain.Revision surgery took place with no stryker rep present.It is unknown if there are any intra-operative findings.A size 6 cr femur, 6x11 cs insert, size 6 baseplate, and an a32 x3 asymmetric all-poly patellar component (implanted using the mako robot in january 2018) were revised.Rep has supplied the primary operative report and pre-revision x-rays.

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8955599
• MDR Text Key: 156283165
• Report Number: 3005985723-2019-00631
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR