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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3D KNEE INSERT, 3D EX SZ 8LT 9MM

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ENCORE MEDICAL L.P. 3D KNEE INSERT, 3D EX SZ 8LT 9MM Back to Search Results
Model Number 391-09-708
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Osteolysis (2377)
Event Date 01/07/2022
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: original poly was removed because it was compressed, causing leakage into the screw holes causing osteolysis. Screws were removed and holes were plugged. A new 8/11 poly was implanted.
 
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Brand Name3D KNEE
Type of DeviceINSERT, 3D EX SZ 8LT 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
kiersten soderman
9800 metric blvd
austin, TX 78758-5445
MDR Report Key13372126
MDR Text Key284613364
Report Number1644408-2022-00103
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 02/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2018
Device Model Number391-09-708
Device Catalogue Number391-09-708
Device Lot Number59603465
Was Device Available for Evaluation? No
Date Manufacturer Received01/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2013
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: 01/27/2022 Patient Sequence Number: 1
Treatment
010-55-025 LOT 006A1075; 010-55-025 LOT 006A1096; 010-55-030 LOT 007A1050; 010-55-035 LOT 009A1032
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