• 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 SHORT NECK 50MM 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 SHORT NECK 50MM HIP COMPONENT Back to Search Results
Model Number 38AM5004
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Metal Related Pathology (4530)
Event Type  Injury  
Manufacturer Narrative
See investigation attached.
 
Event Description
Allegedly, the patient was revised due to metallosis (no pseudotumor) and the failure of modular neck at the neck/stem junction taper (neck broken).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCONSERVE A-CLASS BFH HEAD SHORT NECK 50MM
Type of DeviceHIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer (Section G)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer Contact
5677 airline road
arlington, TN 38002
9018674771
MDR Report Key11585808
MDR Text Key242881689
Report Number3010536692-2021-00180
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number38AM5004
Device Catalogue Number38AM5004
Device Lot Number065229812
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/12/2021
Event Location No Information
Date Manufacturer Received03/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/29/2021 Patient Sequence Number: 1
-
-