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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL TRIAL SLAPHAMMER; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
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MAKO SURGICAL CORP. FEMORAL TRIAL SLAPHAMMER; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P Back to Search Results
Catalog Number 111140
Medical Device Problem Codes Break (1069); Fracture (1260)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 12/14/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there have been 5 other similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
 
Event or Problem Description
Tip snapped removing fem trial.
 
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Brand Name
FEMORAL TRIAL SLAPHAMMER
Common Device Name
KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key8239975
Report Number3005985723-2019-00047
Device Sequence Number1658110
Product Code NPJ
UDI-Device Identifier00848486002732
UDI-Public00848486002732
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K090763
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/11/2019
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 Number111140
Device Lot Number06060515
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/14/2018
Initial Report FDA Received Date01/11/2019
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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