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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L. P. HIGHLY CROSS LINKED KNEE DOMED TRI-PEG PATELLA, 35X9MM, E-PLUS

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ENCORE MEDICAL L. P. HIGHLY CROSS LINKED KNEE DOMED TRI-PEG PATELLA, 35X9MM, E-PLUS Back to Search Results
Model Number 130-03-735
Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)
Patient Problem Failure of Implant (1924)
Event Date 04/12/2021
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 patient presented to revising surgeon with a fractured patella.
 
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Brand NameHIGHLY CROSS LINKED 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 Key11782862
MDR Text Key249222371
Report Number1644408-2021-00413
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 06/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/03/2022
Device Model Number130-03-735
Device Catalogue Number130-03-735
Device Lot Number156N1212
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/09/2017
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: 05/06/2021 Patient Sequence Number: 1
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