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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 4LT 9MM

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ENCORE MEDICAL L.P. 3D KNEE INSERT, 3D EX SZ 4LT 9MM Back to Search Results
Model Number 391-09-704
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Inflammation (1932); Discomfort (2330)
Event Date 10/07/2021
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 - patient stated that she had underwent several sessions of physical therapy with little alleviation in symptoms. Knee has had ongoing swelling and discomfort. Patient notified surgeon of post operative discomfort.
 
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Brand Name3D KNEE
Type of DeviceINSERT, 3D EX SZ 4LT 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 Key12618958
MDR Text Key276094003
Report Number1644408-2021-01074
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
Report Date 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/24/2022
Device Model Number391-09-704
Device Catalogue Number391-09-704
Device Lot Number281G1939
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/12/2021 Patient Sequence Number: 1
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