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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3D KNEE INSERT, 3D EX SZ 8RT 15MM

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ENCORE MEDICAL L.P. 3D KNEE INSERT, 3D EX SZ 8RT 15MM Back to Search Results
Model Number 392-15-708
Device Problems Naturally Worn (2988); Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 12/07/2020
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 poly wear.
 
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Brand Name3D KNEE
Type of DeviceINSERT, 3D EX SZ 8RT 15MM
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 78758-5445
MDR Report Key11105639
MDR Text Key224733513
Report Number1644408-2020-01214
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912121040
UDI-Public(01)00888912121040
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091956
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 03/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number392-15-708
Device Catalogue Number392-15-708
Device Lot Number357G1051A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/26/2019
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: 01/03/2021 Patient Sequence Number: 1
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