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 Pain (1994); Injury (2348)

Event Date 05/08/2020

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.Device not returned.

Event Description

Revised femur of uni pka.Case type: pka (mics).

Manufacturer Narrative

Reported event: it was reported, "revised femur of uni pka.Case type:pka (mics)¿.It was also noted in the communication log: cement mantle was loose, femur had cement but cement didn't interdigitate to bone, this case was a revision of a previous partial knee mako case.Product evaluation and results: review of the case session files was not performed as case session data was not provided.Product history review: review of the device history records associated with (b)(6) indicate that on 10 september 2019 quality inspection procedures were completed with no reported discrepancies.Complaint history review: a search of the complaint database under device identification pn 219999 reports similar complaints for pka software ¿ other.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the case session data, pre and post-operative x-rays, as well as patient history and follow-up notes 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.H3 other text : device not returned.

Event Description

Revised femur of uni pka.Case type:pka (mics).

• 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: 10055924
• MDR Text Key: 191003252
• Report Number: 3005985723-2020-00200
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• 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: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 49 YR