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

Model Number 209999

Device Problems Display Difficult to Read (1181); Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problem Joint Dislocation (2374)

Event Date 12/22/2020

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

Dr.Revised a cup/liner/head of a left total hip due to dislocation.Original surgery was on (b)(6) 2019.He implanted another primary cup adjusting the cup position relative to the original and used mdm.

Manufacturer Narrative

Reported event.An event regarding dislocation involving a mako tha software was reported.The event was not confirmed.Method & results -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 rob163 was inspected on 21 sept 2011 and the quality inspection procedures were completed with no reported discrepancies -complaint history review: a review of complaints in trackwise related to p/n 209999, robot number: rob163 shows 0 similar complaints for tha software - other(dislocation).Conclusions: it was reported that the patient's hip was revised due to dislocation and another primary shell was implanted adjusting the shell position relative to the original.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, return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report 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.Device not available.

Event Description

Dr.Revised a cup/liner/head of a left total hip due to dislocation.Original surgery was on (b)(6) 2019.He implanted another primary cup adjusting the cup position relative to the original and used mdm.Update 23/december/2020 wg: rep provided primary and revision usage sheets and reported that no further information is available from the hospital or surgeon.

• 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: 11178685
• MDR Text Key: 227076248
• Report Number: 3005985723-2021-00008
• 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: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR