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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 209999
Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)
Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
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.
 
Event Description
Patient required a revision of the cup today due to it loosening.The original case was (b)(6) 2020; due to patient anatomy at that time, the surgeon opted to use a trident tritanium multihole (509-02-56e).Surgeon requested screws.Torx screws were provided (2030-6516-1 and 2030-6530-1).Liner was impacted and the femur was completed.I became aware today (5/8/2020) that the patient required a revision of the cup.
 
Manufacturer Narrative
Reported event: it was reported, ¿patient required a revision of the cup today due to it loosening.The original case was (b)(6) 2020; due to patient anatomy at that time, the surgeon opted to use a trident tritanium multihole (509-02-56e).Surgeon requested screws.Torx screws were provided (2030-6516-1 and 2030-6530-1).Liner was impacted and the femur was completed.I became aware today (5/8/2020) that the patient required a revision of the cup.¿.Method & results: product evaluation and results: from the logged messages it was confirmed that the robot registration and pelvic checkpoints passed.The robot passed pre-surgery checks on the day of the surgery.The patient bone registration was not ideal possibly due to challenges in patient bone structure.The implanted acetabular shell (trident tritanium shell multihole) was not the same as the planned acetabular shell (trident tritanium shell).The depth of impaction captured during surgery indicates that the acetabular cup was placed 5 mm proud of the planned location.There were no errors or information in the log files to suspect robot software or hardware issues during surgery.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant rejected stating : undated ap pelvis labelled "planned" with uncemented templates of left tha in situ, no screws in acetabulum, reduced and nominal position.Implant labels dated (b)(6) 2020 : 56 trident tritanium hemispherical shell, 36/0 degree x-3 poly insert, 2 torx cancellous screws, #7 anato hip stem, 36/-2,5 v-40 biolox head.No clinical or pmh, no patient demographics, no operative reports, no post op x- rays, no exam of explanted components.The implant labels confirm the use of torx screws noted in the event description, but the loose cup is not confirmed.No medical report is possible based upon the information supplied." product history review: a review of device history records shows that rob437 was inspected on 26 may 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 reports no similar complaints for tha software - other.Conclusions: it was reported that patient required a revision of the cup today due to it loosening.The event is not confirmed.A review of the provided medical records and/or x-rays by a clinical consultant rejected stating : undated ap pelvis labelled "planned" with uncemented templates of left tha in situ, no screws in acetabulum, reduced and nominal position.Implant labels dated (b)(6) 2020 : 56 trident tritanium hemispherical shell, 36/0 degree x-3 poly insert, 2 torx cancellous screws, #7 anato hip stem, 36/-2,5 v-40 biolox head.No clinical or pmh, no patient demographics, no operative reports, no post op x- rays, no exam of explanted components.The implant labels confirm the use of torx screws noted in the event description, but the loose cup is not confirmed.No medical report is possible based upon the information supplied." further to this, a review of the log/session files confirmed that the robot registration, pelvic checkpoints and pre-surgery checks all passed.It was noted that the patient bone registration was not ideal and this may have been due to patient bone structure.The implanted acetabular shell (trident tritanium shell multihole) was not the same as the planned acetabular shell (trident tritanium shell).The depth of impaction captured during surgery indicates that the acetabular cup was placed 5 mm proud of the planned location.Again it is possible this was due to the patients bone structure.The exact cause of the event could not be determined because insufficient information was provided.Additional information such as the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.Post- op x-rays are also required in order to complete a medical review determination.No additional investigation or specific actions are required at this time.If additional information is received, then the complaint will be reopened.System is ready for use.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no ncs or capas associated with the product and failure mode reported in this event.
 
Event Description
Patient required a revision of the cup today due to it loosening.The original case was (b)(6) 2020; due to patient anatomy at that time, the surgeon opted to use a trident tritanium multihole (509-02-56e).Surgeon requested screws.Torx screws were provided (2030-6516-1 and 2030-6530-1).Liner was impacted and the femur was completed.I became aware today (5/8/2020) that the patient required a revision of the cup.
 
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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 Key10105424
MDR Text Key193646938
Report Number3005985723-2020-00206
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486030407
UDI-Public00848486030407
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
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 Received06/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number209999
Device Catalogue Number209999
Was Device Available for Evaluation? No
Date Manufacturer Received10/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age69 YR
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