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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
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MAKO SURGICAL RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS Back to Search Results
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Bone Fracture(s) (1870)
Event Date 07/02/2014
Event Type  Injury  
Event Description
The surgeon had performed bilateral partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants.The right knee appeared to have tibial subsidence, and the surgeon stated that the implant appeared loose.Therefore, the surgeon performed a total knee revision procedure.
 
Manufacturer Narrative
As part of normal complaint f/u, an eval of the event has been initiated at mako surgical.No rio case session files are available for review.The revised implant was also not returned for investigation.The pt x-ray does appear to confirm the tibial subsidence.Further investigation is ongoing, and a supplemental report will be filed if further info is obtained.
 
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Brand Name
RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
Type of Device
COMPARTMENTAL KNEE PROSTHESIS
Manufacturer (Section D)
MAKO SURGICAL
ft. lauderdale FL
Manufacturer Contact
william tapia
2555 davie rd., suite 110
ft. lauderdale, FL 33317
9546280605
MDR Report Key3981162
MDR Text Key17390503
Report Number3005985723-2014-00094
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 07/02/2014
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 07/02/2014
Initial Date FDA Received07/24/2014
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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