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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. HIGHLY CROSS-LINKED TIBIAL INSERT INSERT, 3D EX SZ 7LT 9MM

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ENCORE MEDICAL L.P. HIGHLY CROSS-LINKED TIBIAL INSERT INSERT, 3D EX SZ 7LT 9MM Back to Search Results
Model Number 391-09-707
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Pain (1994)
Event Date 11/19/2019
Event Type  Injury  
Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
 
Event Description
Revision surgery - due to knee pain.
 
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Brand NameHIGHLY CROSS-LINKED TIBIAL INSERT
Type of DeviceINSERT, 3D EX SZ 7LT 9MM
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin TX 78758 5445
Manufacturer (Section G)
ENCORE MEDICAL L.P.
9800 metric blvd
austin TX 78758 5445
Manufacturer Contact
teffany hutto
9800 metric blvd
austin, TX 78758-5445
MDR Report Key9490691
MDR Text Key171976510
Report Number1644408-2019-01250
Device Sequence Number1
Product Code OIY
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2019
Device Model Number391-09-707
Device Catalogue Number391-09-707
Device Lot Number59605201
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/09/2014
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: 12/18/2019 Patient Sequence Number: 1
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