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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, 29X8MM, E-PLUS

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ENCORE MEDICAL L.P MOVATION KNEE DOMED TRI-PEG PATELLA, 29X8MM, E-PLUS Back to Search Results
Model Number 130-03-729
Device Problem Mechanical Problem (1384)
Patient Problem Insufficient Information (4580)
Event Date 12/08/2020
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
Second revision surgery - patella tracking issue and possible extensor mechanism augmentation.
 
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Brand NameMOVATION KNEE
Type of DeviceDOMED TRI-PEG PATELLA, 29X8MM, 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
kiersten soderman
9800 metric blvd.
austin, TX 78758-5445
MDR Report Key11120385
MDR Text Key225247319
Report Number1644408-2020-01212
Device Sequence Number1
Product Code OIY
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,Followup
Report Date 11/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number130-03-729
Device Catalogue Number130-03-729
Device Lot Number154N1219
Was Device Available for Evaluation? No
Date Manufacturer Received04/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/20/2017
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: 01/05/2021 Patient Sequence Number: 1
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