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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_RESTORIS MCK ONLAY TIBIAL BASEPLATE SIZE 4 RM/LL; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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MAKO SURGICAL CORP. UNKNOWN_RESTORIS MCK ONLAY TIBIAL BASEPLATE SIZE 4 RM/LL; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number UNK_OFL
Device Problems Failure to Osseointegrate (1863); Loss of Osseointegration (2408)
Patient Problem Inadequate Osseointegration (2646)
Event Date 03/21/2022
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation.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 left uni knee was revised.As reported by rep: "tibial component was revised and replaced with a bigger sized tibial tray and upsized poly as well." a size 3 rm/ll baseplate and 3x8 insert were revised to a size 4 rm/ll baseplate and 4x9 insert.Update: "reason for revision: aseptic loosening on tibial component.".
 
Event Description
It was reported that the patient's left uni knee was revised.As reported by rep: "tibial component was revised and replaced with a bigger sized tibial tray and upsized poly as well." a size 3 rm/ll baseplate and 3x8 insert were revised to a size 4 rm/ll baseplate and 4x9 insert.Update: "reason for revision: aseptic loosening on tibial component.".
 
Manufacturer Narrative
Reported event: an event regarding loosening involving an unknown baseplate was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to aseptic loosening on tibial component.The event could not be confirmed as insufficient information was provided.Further information such as device identification and return, pre- and post-operative x-rays, 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 additional information become available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.
 
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Brand Name
UNKNOWN_RESTORIS MCK ONLAY TIBIAL BASEPLATE SIZE 4 RM/LL
Type of Device
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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
perla zima
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key14119752
MDR Text Key289350837
Report Number3005985723-2022-00045
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Catalogue NumberUNK_OFL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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) Required Intervention; Hospitalization;
Patient Age57 YR
Patient SexFemale
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