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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK PATELLA RESURFACING ROUND DOME-35MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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MAKO SURGICAL CORP. MCK PATELLA RESURFACING ROUND DOME-35MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM Back to Search Results
Catalog Number 180320-4
Device Problems Degraded (1153); Device Dislodged or Dislocated (2923)
Patient Problem Subluxation (4525)
Event Date 05/17/2021
Event Type  Injury  
Manufacturer Narrative
As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
 
Event Description
It was reported that the patient's right knee was revised due to subluxation of the patella.Intra-operatively, excessive wear of the patellar component was noted.A mako patellofemoral knee was revised to a tka.Rep reported that the devices are allegedly available for return, and that no further information will be released by the hospital or surgeon.
 
Event Description
It was reported that the patient's right knee was revised due to subluxation of the patella.Intra-operatively, excessive wear of the patellar component was noted.A mako patellofemoral knee was revised to a tka.Rep reported that the devices are allegedly available for return, and that no further information will be released by the hospital or surgeon.
 
Manufacturer Narrative
Reported event: an event regarding dislocation and wear involving a mako patella component was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection & ma - examination by engineer indicated burnishing, scratching and third body indentation were observed on the insert.These are common damage modes of uhmwpe.Explantation damage was also observed on the insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Dimensional inspection: not performed because the device was returned damaged.Functional inspection: not performed because the device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.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 have been no other similar events for the lot referenced.Conclusions: an event regarding subluxation of the patella was reported.Intra-operatively, excessive wear of the patellar component was noted.The event was not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
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Brand Name
MCK PATELLA RESURFACING ROUND DOME-35MM
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 Key12010065
MDR Text Key256531931
Report Number3005985723-2021-00106
Device Sequence Number1
Product Code NPJ
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 09/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number180320-4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2021
Date Manufacturer Received08/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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