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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 6RT 9MM

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ENCORE MEDICAL L.P. 3DKNEE INSERT, 3D EX SZ 6RT 9MM Back to Search Results
Model Number 392-09-706
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Abrasion (1689)
Event Date 04/24/2019
Event Type  Injury  
Event Description
Revision surgery - due to the implant having not normal marks after 6 months of use. The abrasion is not normal for 6 months.
 
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Brand Name3DKNEE
Type of DeviceINSERT, 3D EX SZ 6RT 9MM
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin, tx 78758-5445 TX 78758 5445
Manufacturer (Section G)
ENCORE MEDICAL L.P.
9800 metric blvd
austin, tx 78758-5445 TX 78758 5445
Manufacturer Contact
teffany hutto
9800 metric blvd
austin, tx 78758-5445, TX 78758-5445
MDR Report Key8672699
MDR Text Key147157804
Report Number1644408-2019-00536
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K091956
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number392-09-706
Device Catalogue Number392-09-706
Device Lot Number328G1130
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 Received11/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/17/2018
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: 06/05/2019 Patient Sequence Number: 1
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