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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. MOVATION KNEE DOMED TRI-PEG PATELLA, 32X8MM, E-PLUS

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ENCORE MEDICAL L.P. MOVATION KNEE DOMED TRI-PEG PATELLA, 32X8MM, E-PLUS Back to Search Results
Model Number 130-03-732
Device Problems Unstable (1667); Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 09/18/2020
Event Type  Injury  
Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
 
Event Description
Revision surgery - due to instability.
 
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Brand NameMOVATION KNEE
Type of DeviceDOMED TRI-PEG PATELLA, 32X8MM, E-PLUS
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
teffany hutto
9800 metric blvd
austin, tx 78758-5445 
MDR Report Key10691488
MDR Text Key211738832
Report Number1644408-2020-00947
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912108539
UDI-Public(01)00888912108539
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113756
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 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number130-03-732
Device Catalogue Number130-03-732
Device Lot Number155N1583
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/07/2019
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: 10/16/2020 Patient Sequence Number: 1
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