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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
Health Effect - Clinical Codes Inflammation (1932); Discomfort (2330)
Date of Event 10/07/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
 
Event or Problem 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 Name
3D KNEE
Common Device Name
INSERT, 3D EX SZ 4LT 9MM
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin, tx 78758-5445
MDR Report Key12618958
Report Number1644408-2021-01074
Device Sequence Number17273622
Product Code OIY
UDI-Device Identifier00888912118941
UDI-Public(01)00888912118941
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K091956
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date04/24/2022
Device Model Number391-09-704
Device Catalogue Number391-09-704
Device Lot Number281G1939
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/25/2021
Initial Report FDA Received Date10/12/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age62 YR
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