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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. 3DKNEE; INSERT, 3D EX SZ 7LT 11MM
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ENCORE MEDICAL, L.P. 3DKNEE; INSERT, 3D EX SZ 7LT 11MM Back to Search Results
Model Number 391-11-707
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Loss of Range of Motion (2032); Ambulation Difficulties (2544)
Event Date 11/18/2015
Event Type  Injury  
Event Description
Revision surgery - due to the patient presenting with limited motion.The surgeon cleaned up the area and replaced the poly as the original was moved to access soft tissue.
 
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Brand Name
3DKNEE
Type of Device
INSERT, 3D EX SZ 7LT 11MM
Manufacturer (Section D)
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin TX 78758
Manufacturer (Section G)
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin TX 78758
Manufacturer Contact
teffany hutto
9800 metric blvd.
austin, TX 78758-5445
5128346255
MDR Report Key5312228
MDR Text Key241275902
Report Number1644408-2015-00715
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912119245
UDI-Public(01)00888912119245
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091956
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 11/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2019
Device Model Number391-11-707
Device Catalogue Number391-11-707
Device Lot Number155N1047
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/18/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/14/2014
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; Required Intervention;
Patient Age65 YR
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