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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL RESTORSIS MULTICOMPARTMENTAL KNEE PROSTHESIS
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MAKO SURGICAL RESTORSIS MULTICOMPARTMENTAL KNEE PROSTHESIS Back to Search Results
Device Problem Device Slipped (1584)
Patient Problem No Code Available (3191)
Event Date 03/27/2014
Event Type  Injury  
Event Description
A patient had received a partial knee arthroplasty, which was performed using the robotic arm interactive orthopedic system (rio) and restorsis multicompartmental knee implants on (b)(6) 2011.The surgeon performed a revision on the date of event due to implant loosening.
 
Manufacturer Narrative
As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.The patient was reported to have been doing well prior to loosening of the femoral component.During the revision procedure, the surgeon found that the femoral component had come loose due to avascular necrosis (avn).Evaluation is ongoing, and a supplemental report will be filed if further information is obtained.
 
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Brand Name
RESTORSIS MULTICOMPARTMENTAL KNEE PROSTHESIS
Type of Device
COMPARTMENTAL KNEE PROSTHESIS
Manufacturer (Section D)
MAKO SURGICAL
ft. lauderdale FL
Manufacturer Contact
william tapia
2555 davie rd.
ft. lauderdale, FL 33317
9546280605
MDR Report Key3786905
MDR Text Key4433457
Report Number3005985723-2014-00044
Device Sequence Number1
Product Code NPJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090763
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/27/2014
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/27/2014
Initial Date FDA Received04/21/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO)
Patient Outcome(s) Required Intervention;
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