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. LINEAGE TRANSCEND CERAMIC ACETABULAR LINER; 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. LINEAGE TRANSCEND CERAMIC ACETABULAR LINER; HIP COMPONENT Back to Search Results
Model Number 73003258
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Loss of Range of Motion (2032)
Type of Reportable Event Serious Injury
Event or Problem Description
Allegedly, patient impinges on malposition cup.Cup was cut out and replaced with biomet cup and liner w/screws.Neck would not came out w/our extraction, our head was pulled and 28mm from mpo was put into a biomet dual mobility head.(right hip) components not revised: profemur® neck neutral / product id: pha01202 / lot no: 065207269, profemur® z stem size 6 stem / product id: pha00242 / lot no: u0366091.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LINEAGE TRANSCEND CERAMIC ACETABULAR LINER
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key10934854
Report Number3010536692-2020-00721
Device Sequence Number982816
Product Code MRA
UDI-Device IdentifierM684730032581
UDI-PublicM684730032581
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2006
Device Explanted Year2020
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/02/2020
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 Health Professional
Device Model Number73003258
Device Catalogue Number73003258
Device Lot Number11359332
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/19/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/19/2020
Initial Report FDA Received Date12/02/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age58 YR
-
-