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. CONSERVE A-CLASS BFH HEAD MEDIUM NECK 36MM; 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. CONSERVE A-CLASS BFH HEAD MEDIUM NECK 36MM; HIP COMPONENT Back to Search Results
Model Number 38AM3600
Medical Device Problem Codes Material Disintegration (1177); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes Metal Related Pathology (4530); Unequal Limb Length (4534)
Type of Reportable Event Serious Injury
Event or Problem Description
Allegedly, the patient underwent a revision surgery due to dislocation, metal debris with pseudo-tumor formation and leg length discrepancy.Component not revised: dspcgc50 dynasty® pc shell 50mm, group c, lot: 129999843.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONSERVE A-CLASS BFH HEAD MEDIUM NECK 36MM
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key11230126
Report Number3010536692-2021-00038
Device Sequence Number3861319
Product Code KWA
UDI-Device IdentifierM68438AM36001
UDI-PublicM68438AM36001
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K051348
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2019
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/26/2021
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 Number38AM3600
Device Catalogue Number38AM3600
Device Lot Number039828317
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/05/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/05/2021
Initial Report FDA Received Date01/26/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
-
-