Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO ROBOTIC ARM 3.1; ORTHOPEDIC STEREOTAXIC INSTRUMENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAKO SURGICAL CORP. MAKO ROBOTIC ARM 3.1; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 219999
Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577)
Event Date 06/22/2020
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
As reported: "pt presented to emergency department w/ complaint of pain and swelling to right lower extremity.Xray showed perihardware fracture and pt admitted.Pt placed in knee immobilizer on (b)(6) 2020 and discharged to inpatient rehab.".
 
Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving a mako tka software was reported.The event was confirmed through review of the provided medical records.Method & results: product evaluation and results: review of the case session files was not performed as case session data was not provided.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: confirmation: a periprosthetic distal femur fracture was confirmed postoperatively via x-ray reports and hospital notes.Root cause: the root cause cannot be determined without additional records and in particular radiographs.The question is really where exactly did the fracture occur? did it extend into one of the pin holes from the mako, into the box cut, or independent of these stress risers.Product history review: a review of device history records shows that (b)(6) was inspected and the quality inspection procedures were completed with no reported discrepancies complaint history review: a review of complaints in trackwise related to p/n 219999, robot number: (b)(6) shows 0 similar complaints for tka software - other.Conclusions: a review of the provided medical records by a clinical consultant stated the following comment: a periprosthetic distal femur fracture was confirmed postoperatively via x-ray reports and hospital notes.The root cause cannot be determined without additional records and in particular radiographs.The question is really where exactly did the fracture occur? did it extend into one of the pin holes from the mako, into the box cut, or independent of these stress risers.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 are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and/ or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.
 
Event Description
As reported: "pt presented to emergency department w/ complaint of pain and swelling to right lower extremity.Xray showed perihardware fracture and pt admitted.Pt placed in knee immobilizer on (b)(6) 2020 and discharged to inpatient rehab." update: "nondisplaced vertically oriented distal femoral perihardware fracture.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MAKO ROBOTIC ARM 3.1
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key11120223
MDR Text Key225282628
Report Number3005985723-2021-00007
Device Sequence Number1
Product Code OLO
UDI-Device Identifier07613327395280
UDI-Public07613327395280
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 03/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number219999
Device Catalogue Number219999
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/14/2020
Initial Date FDA Received01/05/2021
Supplement Dates Manufacturer Received03/03/2021
Supplement Dates FDA Received03/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age86 YR
Patient Weight48
-
-