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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL TRIAL STD RM/LL SIZE 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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MAKO SURGICAL CORP. FEMORAL TRIAL STD RM/LL SIZE 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM Back to Search Results
Catalog Number 170515
Device Problems Material Fragmentation (1261); Material Deformation (2976); Naturally Worn (2988); Scratched Material (3020)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Event Date 04/12/2017
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Event Description
During the trialing stage of the surgery the dr removed the poly and noticed it was very worn down and small fragments were noticed in the patient.The dr removed the plastic fragments from the patients so there was no patient harm in the case but he requested they be replaced since many of them are so worn down.Both uni trays were opened since one of the femur trials was stripped where the mini slap would be inserted so he had trouble getting it out of the patient.Surgical delay to remove fragments.
 
Manufacturer Narrative
An event regarding thread damage involving a mako trial was reported.The event was confirmed.Method & results: device evaluation and results: a visual inspection of the returned trial noted that the device was returned in used condition.Provided images confirm the scratches on the trials and threads were observed to be damaged.Also material analysis engineer indicated that damage observed on threads of device consistent with cross threading.Medical records received and evaluation: not performed as patient factors did not contribute to the event.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the event was confirmed as per visual inspection of the returned device which shows that the threads were damaged.Examination of the returned device, in consultation with the material analysis engineer, indicated that the damage observed on threads of device consistent with cross threading.
 
Event Description
During the trialing stage of the surgery the dr removed the poly and noticed it was very worn down and small fragments were noticed in the patient.The dr removed the plastic fragments from the patients so there was no patient harm in the case but he requested they be replaced since many of them are so worn down.Both uni trays were opened since one of the femur trials was stripped where the mini slap would be inserted so he had trouble getting it out of the patient.Surgical delay to remove fragments.
 
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Brand Name
FEMORAL TRIAL STD RM/LL SIZE 5
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 Key6559139
MDR Text Key75010479
Report Number3005985723-2017-00211
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 company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number170515
Device Lot Number26331111
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received06/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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