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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 4-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 4-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM Back to Search Results
Model Number 180704-1
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/12/2020
Event Type  malfunction  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There has been one other similar event for the lot referenced which occurred during the same procedure for the same patient.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.
 
Event Description
Partial knee restoris mck onlay tibial insert of size 4*8mm was not fitting properly into tibial baseplate of size 4 left medial.Update: "length of delay approximately 20minutes." update: "tibial baseplate size 4 lm was implanted and later during installing poly 4*8mm (2 qty) surgeon found it difficult to install the poly.He tried with second 4*8 mm poly but still could not able to install into the base plate.Finally poly 4*9mm was used for the procedure." case type: pka, left side.
 
Manufacturer Narrative
Reported event: an event regarding seating/locking issue involving mako insert was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.Nothing of note could be determined from the photograph provided.Material analysis, 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.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.H3 other text : device not returned.
 
Event Description
Partial knee restoris mck onlay tibial insert of size 4*8mm was not fitting properly into tibial baseplate of size 4 left medial.Update: "length of delay approximately 20minutes." update: "tibial baseplate size 4 lm was implanted and later during installing poly 4*8mm (2 qty) surgeon found it difficult to install the poly.He tried with second 4*8 mm poly but still could not able to install into the base plate.Finally poly 4*9mm was used for the procedure." case type: pka, left side.
 
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Brand Name
MCK TIBIAL ONLAY INSERT-SZ 4-8MM
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 Key10313886
MDR Text Key200060654
Report Number3005985723-2020-00238
Device Sequence Number1
Product Code NPJ
UDI-Device Identifier00848486000882
UDI-Public00848486000882
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,other
Type of Report Initial,Followup
Report Date 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2021
Device Model Number180704-1
Device Catalogue Number180704-1
Device Lot Number12310816-1
Was Device Available for Evaluation? No
Date Manufacturer Received08/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age77 YR
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