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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P 3D KNEE; INSERT, 3D SIZE8 X 15MM L DCM
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ENCORE MEDICAL L.P 3D KNEE; INSERT, 3D SIZE8 X 15MM L DCM Back to Search Results
Model Number 391-15-608
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 11/11/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
 
Event or Problem Description
Revision surgery - the insert from the original surgery wore to the point of failure.The femoral and tibial components were retained and the insert was successfully replaced.
 
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Brand Name
3D KNEE
Common Device Name
INSERT, 3D SIZE8 X 15MM L DCM
Manufacturer (Section D)
ENCORE MEDICAL L.P
9800 metric blvd
austin, tx 78758-5445
MDR Report Key11133583
Report Number1644408-2020-01221
Device Sequence Number837631
Product Code JWH
UDI-Device Identifier00888912119689
UDI-Public(01)00888912119689
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K020114
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2009
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/07/2021
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 Date09/24/2023
Device Model Number391-15-608
Device Catalogue Number391-15-608
Device Lot Number645B1022
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/11/2020
Initial Report FDA Received Date01/07/2021
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 Age63 YR
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