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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P BIPOLAR HIP SHELL, BIPOLAR, MODULAR, ENCORE, SIZE44

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ENCORE MEDICAL L.P BIPOLAR HIP SHELL, BIPOLAR, MODULAR, ENCORE, SIZE44 Back to Search Results
Model Number 497-28-000
Device Problems Unstable (1667); Appropriate Term/Code Not Available (3191)
Patient Problem Failure of Implant (1924)
Event Date 11/03/2020
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 - revision/ conversion of a bipolar hip to a total due to instability.
 
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Brand NameBIPOLAR HIP
Type of DeviceSHELL, BIPOLAR, MODULAR, ENCORE, SIZE44
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 Key10928550
MDR Text Key218982666
Report Number1644408-2020-01108
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K953510
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 07/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number497-28-000
Device Catalogue Number412-02-044
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/01/2020 Patient Sequence Number: 1
Treatment
412-02-044 LOT UNKNOWN
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