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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 5-9MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
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MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 5-9MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY Back to Search Results
Catalog Number 180705-2
Medical Device Problem Code Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/01/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event or Problem Description
Surgeon made a complaint about the design of the tibial poly locking mechanism.He described the problem being that it is difficult to engage the posterior aspect of the poly into the tibial baseplate.Approximate delay was 5 minutes.
 
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Brand Name
MCK TIBIAL ONLAY INSERT-SZ 5-9MM
Common Device Name
PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key6826738
Report Number3005985723-2017-00404
Device Sequence Number518772
Product Code NPJ
UDI-Device Identifier00848486000929
UDI-Public00848486000929
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
K090763
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number180705-2
Device Lot Number12020716-1
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/01/2017
Initial Report FDA Received Date08/29/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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