Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PRIME A-CLASS XLPE FC LAT LINER 36 MM GROUP C; HIP COMPONENT
  • 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
 

MICROPORT ORTHOPEDICS INC. PRIME A-CLASS XLPE FC LAT LINER 36 MM GROUP C; HIP COMPONENT Back to Search Results
Model Number P2LXFC36
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code No Information (3190)
Date of Event 07/18/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Investigation completed.Evaluation codes added.
 
Event or Problem Description
Allegedly, patient was revised due to aseptic loosening of prosthetic hip.Medwatch number: mw5094811.
 
Additional Manufacturer Narrative
Please void all reports associated with medwatch: 3010536692-2020-00486.There is no deficiency stated against this device.All reports submitted for this medwatch was created and submitted by accident.These reports should be voided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PRIME A-CLASS XLPE FC LAT LINER 36 MM GROUP C
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key10270983
Report Number3010536692-2020-00486
Device Sequence Number14302595
Product Code LPH
UDI-Device IdentifierM684P2LXFC361
UDI-PublicM684P2LXFC361
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 07/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Other
Device Model NumberP2LXFC36
Device Catalogue NumberP2LXFC36
Device Lot Number1773320
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/23/2020
Initial Date Received by Manufacturer 06/23/2020
Supplement Date Received by Manufacturer06/23/2020
Initial Report FDA Received Date07/14/2020
Supplement Report FDA Received Date07/23/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Other; Required Intervention;
-
-