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U.S. Department of Health and Human Services

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

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ENCORE MEDICAL L.P. ALL POLY KNEE DOMED TRI-PEG PATELLA, 35X9MM, E-PLUS Back to Search Results
Model Number 130-03-735
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Failure of Implant (1924)
Event Date 11/26/2019
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 patella pain.
 
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Brand NameALL POLY 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
teffany hutto
9800 metric blvd
austin, tx 78758-5445 
MDR Report Key9511003
MDR Text Key172732067
Report Number1644408-2019-01265
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 08/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/26/2022
Device Model Number130-03-735
Device Catalogue Number130-03-735
Device Lot Number156N1248
Was Device Available for Evaluation? No
Date Manufacturer Received12/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/29/2017
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: 12/23/2019 Patient Sequence Number: 1
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