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: BIOMET FRANCE S.A.R.L. BIOMET PLUS BONE CEMENT 1X40-3
  • 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. BIOMET PLUS BONE CEMENT 1X40-3 Back to Search Results
Catalog Number 3020810401-3
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2021
Event Type  malfunction  
Event Description
It was reported that during the surgery of vanguard knee prosthesis, when opening the cements they realized that between the last bag and the previous one there was powder loose.No adverse events have been reported as a result of the malfunction.
 
Manufacturer Narrative
(b)(4).Report source, foreign - event occurred in (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.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The 2 products were returned and lab analysis was performed.The product analysis shows that the inner pouch sealing is damaged ofr both returned products.The reported event is confirmed.Investigation results concluded that the reported event was due to packaging issue (sealing process).Corrective action has been initiated to address reported issue.A summary of the investigation was sent to the complainant conveying zimmer biomet conclusions.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 that during the surgery of vanguard knee prosthesis, when opening the cements they realized that between the last bag and the previous one there was powder loose.No adverse events have been reported as a result of the malfunction.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BIOMET PLUS BONE CEMENT 1X40-3
Type of Device
BONE CEMENT
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 Key13141439
MDR Text Key285419743
Report Number3006946279-2022-00004
Device Sequence Number1
Product Code LOD
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2023
Device Catalogue Number3020810401-3
Device Lot NumberA902CH3101
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-