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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK FEMORAL-RM-LL-SZ 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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MAKO SURGICAL CORP. MCK FEMORAL-RM-LL-SZ 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM Back to Search Results
Model Number 180515
Device Problems Insufficient Information (3190); Migration (4003)
Patient Problems Pain (1994); Injury (2348); Joint Dislocation (2374)
Event Date 06/03/2020
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
 
Event Description
It was reported that the patient's right mako partial knee was revised due to medial subsidence of the femoral component, subsidence of the tibial component, and extreme poly wear.Surgeon stated the opinion that poly wear/ debris was a cause or contributor for femoral subsidence.Patient was revised to a total knee.Rep provided the original usage report and explant pictures.The devices are allegedly available for return, otherwise the rep confirmed that no further information will be released.
 
Manufacturer Narrative
Reported event an event regarding subsidence involving a mako femoral component was reported.The event was not confirmed.Method & results: product evaluation and results: material evaluation was completed and indicated the following comments: material loss due to articulation was observed on the lateral side of the implant.The xrf analyzes showed that the components were consistent with their respective drawings.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there has been no other similar events for the lot referenced.Conclusions: material evaluation was indicated the xrf analyzes showed that the components were consistent with their respective drawings.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
It was reported that the patient's right mako partial knee was revised due to medial subsidence of the femoral component, subsidence of the tibial component, and extreme poly wear.Surgeon stated the opinion that poly wear/ debris was a cause or contributor for femoral subsidence.Patient was revised to a total knee.Rep provided the original usage report and explant pictures.The devices are allegedly available for return, otherwise the rep confirmed that no further information will be released.
 
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Brand Name
MCK FEMORAL-RM-LL-SZ 5
Type of Device
PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key10181638
MDR Text Key196010716
Report Number3005985723-2020-00216
Device Sequence Number1
Product Code NPJ
UDI-Device Identifier00848486000646
UDI-Public00848486000646
Combination Product (y/n)N
PMA/PMN Number
K090763
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/30/2020
Device Model Number180515
Device Catalogue Number180515
Device Lot Number454038-M
Was Device Available for Evaluation? No
Date Manufacturer Received08/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age79 YR
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