• 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. HFN 125 DEG 11MM X 180MM PROSTHESIS, TRAUMA

  • 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. HFN 125 DEG 11MM X 180MM PROSTHESIS, TRAUMA Back to Search Results
Catalog Number 814311180
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Osteopenia/ Osteoporosis (2651)
Event Date 02/10/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02765. Concomitant medical devices: part# 281001100; lot# 311650; part# 281001175; lot# m6bad5a; part# 814510110; lot# tp1111310a; part# 814550038; lot# m12600twa; part# 814501095; lot# uc1111295e. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported patient underwent an initial surgery on the right hip approximately nine (9) months ago. Approximately four (4) months postimplantation, patient was revised due to affixus nail cutting out of the femoral head. Surgeon stated patient had poor bone quality and the placement of the lag screw might not have been optimal. Attempts have been made and no further information has been provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHFN 125 DEG 11MM X 180MM
Type of DevicePROSTHESIS, TRAUMA
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 Key10284929
MDR Text Key199984682
Report Number0001825034-2020-02766
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100238
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 11/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number814311180
Device Lot Number082740
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/07/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberNI

Patient Treatment Data
Date Received: 07/16/2020 Patient Sequence Number: 1
-
-