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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, POLY
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MAKO SURGICAL CORP. MCK FEMORAL-RM-LL-SZ 8; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY Back to Search Results
Catalog Number 180518
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Injury (2348)
Date of Event 06/21/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicates devices were manufactured and accepted into final stock on with no reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event or Problem Description
Revision required of mako uni knee.
 
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Brand Name
MCK FEMORAL-RM-LL-SZ 8
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 Key6725828
Report Number3005985723-2017-00315
Device Sequence Number1246744
Product Code NPJ
UDI-Device Identifier00848486000677
UDI-Public00848486000677
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) 07/19/2017
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
Operator of Device Health Professional
Device Expiration Date10/06/2020
Device Catalogue Number180518
Device Lot Number2356231-1
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/21/2017
Initial Report FDA Received Date07/19/2017
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 Hospitalization; Required Intervention;
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