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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK FEMORAL-LM-RL-SZ 2; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY

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MAKO SURGICAL CORP. MCK FEMORAL-LM-RL-SZ 2; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY Back to Search Results
Catalog Number 180502
Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)
Patient Problems Arthritis (1723); Injury (2348); Inadequate Osseointegration (2646)
Event Date 08/16/2017
Event Type  Injury  
Manufacturer Narrative
The following devices were also listed in this report: mck tibial baseplate-lm/rl-sz 2; cat# 180602; lot# 26030115-01, mck tibial onlay insert-sz 2-9mm; cat# 180702-2; lot# 12150615-1.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
Surgeon revised a mako uni medial left knee for disease progression to the pf joint.
 
Manufacturer Narrative
An event regarding a revision for patients' disease progression was reported.The event was not confirmed.A visual, functional and dimensional inspection could not be performed as the device was not returned.The provided medical information was submitted to a consulting clinician who indicated: "x-ray printouts available for review include a series dated (b)(6) 2015, which is an ap of both knees and lateral of the left knee, demonstrating bilateral cemented medial uka with the left knee noted on the tibial component to be loose and subsided anteriorly, and patello-femoral arthritic changes are noted.No clinical or past medical history, no patient demographics, and no examination of explanted components are available.The commonest cause of revision of a unicompartmental knee to a total knee arthroplasty is progression of arthritis to the other knee compartments.The second commonest cause is loosening or subsidence of the uka components.Both appear relevant to this case.There is no evidence of factors of faulty component design, manufacturing or materials having contributed to this clinical situation." device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies there has been no other event for the lot referenced.The reported event was confirmed as per provided medical records reviewed by consulting clinician who indicated that tibial component to be loose and subsided anteriorly in the left knee.He further indicated that the commonest cause of revision of a unicompartmental knee to a total knee arthroplasty is progression of arthritis to the other knee compartments while the second commonest cause is loosening or subsidence of the uka components and both appear relevant to this case as there is no evidence of factors of faulty component design, manufacturing or materials having contributed to this clinical situation.Further information such as patient demographics, clinical or past medical history and examination of explanted components are needed to determine the root cause.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
 
Event Description
Surgeon revised a mako uni medial left knee for disease progression to the pf joint.Update 28-sep-2017: ".The tibial component to be loose and subsided anteriorly.The commonest cause of revision of a unicompartmental knee to a total knee arthroplasty is progression of arthritis to the other knee compartments.The second commonest cause is loosening or subsidence of the uka components.Both appear relevant to this case.".
 
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Brand Name
MCK FEMORAL-LM-RL-SZ 2
Type of Device
PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
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 colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6864782
MDR Text Key86122416
Report Number3005985723-2017-00434
Device Sequence Number1
Product Code NPJ
UDI-Device Identifier00848486000547
UDI-Public00848486000547
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,other
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/17/2020
Device Catalogue Number180502
Device Lot Number26520315-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/17/2015
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) Hospitalization; Required Intervention;
Patient Age61 YR
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