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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK FEMORAL- RM-LL- SZ 6; COMPARTMENTAL KNEE PROSTHESIS
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MAKO SURGICAL CORP. MCK FEMORAL- RM-LL- SZ 6; COMPARTMENTAL KNEE PROSTHESIS Back to Search Results
Catalog Number 180516
Device Problems Material Separation (1562); Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 01/19/2015
Event Type  malfunction  
Event Description
An implant that was to be used for a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants was deemed unfit for use as there were shavings inside of the package.The implant was not used and a new implant was opened and used.This event did not affect the outcome of the case which was successful.
 
Manufacturer Narrative
As part of normal complaint follow-up, an evaluation of the event was completed at mako surgical.A supplemental report will be filed when additional information is obtained.
 
Manufacturer Narrative
An event regarding finding shavings inside of the pack was reported.The event was confirmed.Method & results: -devaluation and results: visual analysis confirmed the reported event.-medical records received and evaluation: not performed because there is no indication the event was related to patient factors -device history review: review of the device history records indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been other similar reported event for this lot id.Conclusions: the investigation concluded that implants rub against the tyvek material and creates particulates in the pouch.A capa was initiated to evaluate particulates observed in the pouches and further investigate the root cause.The source of the debris was confirmed to be the tyvek packaging material which interfaces with the rough surface of the contained implant.The root cause of the debris was determined to due friction occurring between the roughened posts of the implant and the tyvek material.Design changes to the sterile packaging were implemented in august 2012 with to correct and prevent the generation of the debris.The reported device was manufactured prior to the implemented changes and is therefore within the scope of capa.
 
Event Description
An implant that was to be used for a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio) and restoris multicompartmental knee (mck) implants was deemed unfit for use as there were shavings inside of the package.The implant was not used and a new implant was opened and used.This event did not affect the outcome of the case which was successful.
 
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Brand Name
MCK FEMORAL- RM-LL- SZ 6
Type of Device
COMPARTMENTAL KNEE PROSTHESIS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer (Section G)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer Contact
keyla navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4524724
MDR Text Key5545144
Report Number3005985723-2015-00015
Device Sequence Number1
Product Code KRR
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,health professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number180516
Device Lot Number26030712-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received11/30/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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