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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNK RIGHT MAKO PKA KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

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MAKO SURGICAL CORP. UNK RIGHT MAKO PKA KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P Back to Search Results
Catalog Number UNK_OFL
Device Problem Insufficient Information (3190)
Patient Problem Scar Tissue (2060)
Event Date 08/30/2017
Event Type  Injury  
Manufacturer Narrative
An event regarding patient factors involving an unknown mako femoral component was reported. The event was not confirmed. Method & results: device evaluation and results: not performed as product was not returned. Clinician review:no medical records were received for review with a clinical consultant. Device history review: could not be performed as lot code information was not provided. Complaint history review: could not be performed as lot code information was not provided. Conclusion: the exact cause of the event could not be determined because insufficient information was provided. Additional information including device details, operative reports, progress notes, x-rays and 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.
 
Event Description
This pi is for the scar tissue debridement on (b)(6) 2017. The following were reported as failures and included in a report received as proof of milestone on an (b)(6). The study coordinator does not recall reporting these previously and the information included here is limited to what was in the report:.
 
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Brand NameUNK RIGHT MAKO PKA
Type of DeviceKNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
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 Key11338838
MDR Text Key234629356
Report Number3005985723-2021-00021
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation
Type of Report Initial
Report Date 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_OFL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2021
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 Treatment Data
Date Received: 02/17/2021 Patient Sequence Number: 1
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