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. MCK FEMORAL-RM-LL-SZ 8; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
  • 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. MCK FEMORAL-RM-LL-SZ 8; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM Back to Search Results
Catalog Number 180518
Device Problem Difficult to Insert (1316)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/11/2018
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Event Description
As reported: when going to implant the femur component the surgeon stated that when the posterior post went in the anterior post would not fixate into the hole.Tried multiple times when cementing component in and it would not seat into the post holes correctly.Please note that the trial 8 rm femur fit into place perfectly on the first try.We confirmed post holes were completely burred and there were no issues with array movement throughout the case.Another 8 rm femur implant was opened and cemented into place with no issues with the post holes seating.Pka case delayed 5 minutes.
 
Event Description
As reported: when going to implant the femur component the surgeon stated that when the posterior post went in the anterior post would not fixate into the hole.Tried multiple times when cementing component in and it would not seat into the post holes correctly.Please note that the trial 8 rm femur fit into place perfectly on the first try.We confirmed post holes were completely burred and there were no issues with array movement throughout the case.Another 8 rm femur implant was opened and cemented into place with no issues with the post holes seating.Pka case delayed 5 minutes.
 
Manufacturer Narrative
An event regarding a fit issue involving a mako femoral component was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection: visual inspection of the device shows "damage consistent with attempted implantation/explantation".Dimensional inspection: a dimensional inspection of the device was performed.The device was deemed to be within spec.Full results of the inspection are attached.Functional inspection: not performed as the failure mode could not be recreated.Material analysis: material analysis is not performed as this is not related to material integrity.Damage consistent with attempted implantation/explantation.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes and x-rays are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MCK FEMORAL-RM-LL-SZ 8
Type of Device
PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key7671332
MDR Text Key113511995
Report Number3005985723-2018-00409
Device Sequence Number1
Product Code NPJ
UDI-Device Identifier00848486000677
UDI-Public00848486000677
Combination Product (y/n)N
PMA/PMN Number
K090763
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 10/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2020
Device Catalogue Number180518
Device Lot Number2356221-1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2018
Date Manufacturer Received10/01/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age49 YR
-
-