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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 6-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 6-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM Back to Search Results
Catalog Number 180706-1
Device Problems Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
Patient Problems Pain (1994); Impaired Healing (2378); Ambulation Difficulties (2544)
Event Date 03/13/2017
Event Type  Injury  
Manufacturer Narrative
The following devices were also listed in this report: mck tibial baseplate-rm/ll-sz 6; cat# 180616; lot# 26160212-01, mck femoral-rm-ll-sz 5; cat# 180515; lot# 26420811-01.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.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
 
Event Description
Right knee: patient called regarding bilateral makoplasty inserts, surgery (b)(6) 2013 both.Surgery went well.Between (b)(6) 2014 both knees started to get sore.Saw surgeon several times, xrays shows everything was fine but still sore, did exercise during physical therapy.Went to a second surgeon for another opinion of which during the physical exam the surgeon could hear rattling.Quality of life is diminishing as a result of his knees and unable to walk for long periods, especially up and down stairs.Told to wear a brace which he says doesn't help or do a revision surgery.He stated that there is loosing.
 
Manufacturer Narrative
An event regarding alleged pain and loosening involving a mako insert was reported.Conclusion: there is no indication that the product reported in this investigation contributed to the event however, based on the medical review the most likely sources of the alleged symptoms described are ¿soft tissue imbalance and progression of osteoarthritis to the other compartments.¿ the insert is an integral part of the tibial component construct and will have to be explanted together with the loose baseplate and no other allegations were made against the insert therefore it is considered as concomitant.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
Right knee: patient called regarding bilateral makoplasty inserts, surgery (b)(6) 2013 both.Surgery went well.Between (b)(6) 2014 both knees started to get sore.Saw surgeon several times, xrays shows everything was fine but still sore, did exercise during physical therapy.Went to a second surgeon for another opinion of which during the physical exam the surgeon could hear rattling.Quality of life is diminishing as a result of his knees and unable to walk for long periods, especially up and down stairs.Told to wear a brace which he says doesn't help or do a revision surgery.He stated that there is loosing.
 
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Brand Name
MCK TIBIAL ONLAY INSERT-SZ 6-8MM
Type of Device
PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer (Section G)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer Contact
cindy chuhinko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6477006
MDR Text Key72270495
Report Number0002249697-2017-01172
Device Sequence Number1
Product Code NPJ
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 consumer,other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/31/2018
Device Catalogue Number180706-1
Device Lot Number12020213-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2013
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) Other;
Patient Age62 YR
Patient Weight74
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