• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P BIPOLAR HIP SHELL, BIPOLAR, MODULAR, ENCORE, SIZE47

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ENCORE MEDICAL L.P BIPOLAR HIP SHELL, BIPOLAR, MODULAR, ENCORE, SIZE47 Back to Search Results
Model Number 412-02-047
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Failure of Implant (1924)
Event Date 03/09/2021
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 - the patient was admitted to the hospital due to a hip dislocation. The original surgeon applied a closed reduction, but that reduction only lasted a few days before she was admitted a second time due to another dislocation. That is when it was determined to revise the prosthesis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBIPOLAR HIP
Type of DeviceSHELL, BIPOLAR, MODULAR, ENCORE, SIZE47
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 Key11614866
MDR Text Key243799135
Report Number1644408-2021-00237
Device Sequence Number1
Product Code KWY
UDI-Device Identifier00888912077385
UDI-Public(01)00888912077385
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
Report Date 05/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number412-02-047
Device Catalogue Number412-02-047
Device Lot Number993B1136
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/29/2019
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: 04/05/2021 Patient Sequence Number: 1
Treatment
497-28-700 LOT 635C1225
-
-