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

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. AURA II HIP HA COATED LEFT SIZE 5 HIP FEMUR PROSTHESIS

  • 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
 

BIOMET FRANCE S.A.R.L. AURA II HIP HA COATED LEFT SIZE 5 HIP FEMUR PROSTHESIS Back to Search Results
Catalog Number P0125H05
Device Problems Fracture (1260); No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)
Patient Problems Bone Fracture(s) (1870); No Information (3190)
Event Date 12/23/2004
Event Type  Injury  
Manufacturer Narrative
(b)(4). 0 degree tm natural cup id 28mm od 48mm , reference 00-7255-048-28, lot 56462484. Zr modular 5 degree 42 taper 28mm std, reference 164126, lot 772841. Foreign report source: (b)(6). The investigation is in progress. 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.
 
Event Description
It was reported that a patient underwent revision (hip, left) due to periprosthetic bone fracture 5 months after implantation. No additional patient consequences were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAURA II HIP HA COATED LEFT SIZE 5
Type of DeviceHIP FEMUR PROSTHESIS
Manufacturer (Section D)
BIOMET FRANCE S.A.R.L.
plateau de lautagne bp75
valence cedex 26903
FR 26903
Manufacturer (Section G)
BIOMET FRANCE S.A.R.L.
plateau de lautagne bp75
valence cedex 26903
FR 26903
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key10008514
MDR Text Key191693442
Report Number3006946279-2020-00065
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,study
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2009
Device Catalogue NumberP0125H05
Device Lot Number0000107650
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/05/2002
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/29/2020 Patient Sequence Number: 1
-
-