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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC TIBIAL INSERT, FIXED BEARING, SIZE 1, POLYETHYLENE, 7MM, RIGHT

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EXACTECH, INC TIBIAL INSERT, FIXED BEARING, SIZE 1, POLYETHYLENE, 7MM, RIGHT Back to Search Results
Catalog Number 350-22-11
Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Joint Dislocation (2374); No Code Available (3191)
Event Date 01/16/2017
Event Type  Injury  
Manufacturer Narrative
This device is used for treatment not diagnosis. The surgeons who use these devices are knowledgeable with techniques and devices to provide the best surgical plan for the patient. There are no reported device malfunctions or problems, the most likely cause of the dislocation of the talar component is surgical and casting techniques.
 
Event Description
It is reported that the surgeon had some ideas on the dislocation of the talar component, ankle implants need to be "tight" and "remind" the personnel doing the casting to not lift the foot by the toes. Associated mfrs for this event: 1038671-2017-00033 & 1038671-2017-000159.
 
Manufacturer Narrative
The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation. Additionally, the device specific information was not provided, precluding a review of the device history record.
 
Event Description
Revision due to dislocation.
 
Manufacturer Narrative
The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation. Additionally, the device specific information was not provided, precluding a review of the device history record.
 
Event Description
Revision due to dislocation.
 
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Brand NameTIBIAL INSERT, FIXED BEARING, SIZE 1, POLYETHYLENE, 7MM, RIGHT
Type of DeviceTIBIAL INSERT
Manufacturer (Section D)
EXACTECH, INC
2320 nw 66th ct
gainesville FL 32653
Manufacturer (Section G)
EXACTECH, INC
2320 nw 66th ct
gainesville FL 32653
Manufacturer Contact
graham cuthbert
2320 nw 66th ct
gainesville, FL 32653
3523771140
MDR Report Key6277112
MDR Text Key132625724
Report Number1038671-2017-00033
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
PMA/PMN Number
K152217
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/16/2017,11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number350-22-11
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Report to Manufacturer01/16/2017
Date Manufacturer Received11/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/26/2016
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: 01/25/2017 Patient Sequence Number: 1
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