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

Model Number 209999

Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 08/06/2020

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

The doctor revised a mako mck medial pkr due to aseptic loosening of the femoral component.He thinks it was due to cement technique at time of implantation.The construct is two years old.There is visible wear on the poly insert.He believes it is too young to have experienced poly wear, and would like the insert to be examined, assessed and reported back to him please.

Manufacturer Narrative

Reported event: it was reported, "doctor revised a mako mck medial pkr due to aseptic loosening of the femoral component.He thinks it was due to cement technique at time of implantation.The construct is two years old.There is visible wear on the poly insert.He believes it is too young to have experienced poly wear, and would like the insert to be examined, assessed and reported back to him please.¿.Product evaluation and results: review of the case session files was not performed as case session data was not provided.Clinician review: no medical records were received for review with a clinical consultant.Product history review a review of device history records shows that rob423 was inspected on 21 july 2016 and the quality inspection procedures were completed with no reported discrepancies.Complaint history review.A search of the complaint database under device identification pn 209999, rob423 reports similar complaints for pka software ¿ other.Conclusions: it was reported that the patient was revised due to aseptic femoral loosening, the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the case session/log data, operative reports, progress notes and x-rays are needed to complete the investigation for determining root cause.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Device not returned.

Event Description

The doctor revised a mako mck medial pkr due to aseptic loosening of the femoral component.He thinks it was due to cement technique at time of implantation.The construct is two years old.There is visible wear on the poly insert.He believes it is too young to have experienced poly wear, and would like the insert to be examined, assessed and reported back to him please.

• 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
• MDR Report Key: 10477465
• MDR Text Key: 205130415
• Report Number: 3005985723-2020-00291
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 91