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. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 S; 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. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 S; HIP COMPONENT Back to Search Results
Model Number PHA04402
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
 
Event or Problem Description
Allegedly, patient was revised due to dislocation.Mpo procotyl implants removed and replaced with mpo dynasty implants.28mm femoral head removed and changed to 32mm femoral head.The surgeon believes that an error in relocating the hip caused the cup to move.(b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 S
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9868205
Report Number3010536692-2020-00261
Device Sequence Number14180541
Product Code LZO
UDI-Device IdentifierM684PHA044021
UDI-PublicM684PHA044021
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
K140043
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/15/2020
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 NumberPHA04402
Device Catalogue NumberPHA04402
Device Lot Number1826426
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/02/2020
Initial Date Received by Manufacturer 03/02/2020
Supplement Date Received by Manufacturer03/02/2020
Initial Report FDA Received Date03/23/2020
Supplement Report FDA Received Date10/15/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age80 YR
-
-