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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, 35X9MM, E-PLUS

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ENCORE MEDICAL L.P. MOVATION KNEE DOMED TRI-PEG PATELLA, 35X9MM, E-PLUS Back to Search Results
Model Number 130-03-735
Device Problems Appropriate Term/Code Not Available (3191); Device Fell (4014)
Patient Problem Fall (1848)
Event Date 01/25/2022
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: due to a fall, patella fell off.
 
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Brand NameMOVATION KNEE
Type of DeviceDOMED TRI-PEG PATELLA, 35X9MM, 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 Key13506112
MDR Text Key285413951
Report Number1644408-2022-00173
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
Report Date 02/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number130-03-735
Device Catalogue Number130-03-735
Device Lot Number156N1335
Was Device Available for Evaluation? No
Date Manufacturer Received02/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/25/2018
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: 02/10/2022 Patient Sequence Number: 1
Treatment
342-14-704 LOT 138T1000
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