• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT PROSTHESIS HIP

  • 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
 

ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT PROSTHESIS HIP Back to Search Results
Catalog Number 00771100440
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the ml taper stem was protruding out of plastic sterile tray inside of the box. The outside box itself was not damaged. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT
Type of DevicePROSTHESIS HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key11787751
MDR Text Key249805616
Report Number0001822565-2021-01208
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00771100440
Device Lot Number62925409
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/22/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

-
-