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. REFOBACIN BONE CEMENT R 1X40-3; BONE CEMENT, ANTIBIOTIC
  • 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. REFOBACIN BONE CEMENT R 1X40-3; BONE CEMENT, ANTIBIOTIC Back to Search Results
Catalog Number 3003940001-3
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/09/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Foreign report source: (b)(6).The device will not be returned to the manufacturer.Therefore it will not be analyzed.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.Zimmer biomet will continue to monitor for trends.
 
Event Description
It has been reported that the inner sterile packaging was found already open during the operation, the doctor used a spare bone cement to complete the operation.No adverse events have been reported as a result of the malfunction.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The device was not returned to the manufacturer.Therefore it could not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.3 complaints have been recorded on refobacin bone cement r 1x40-3, reference 3003940001-3, over the batch a926ba2506.According to available data, the most probable root cause is due to packaging issue (sealing process).Corrective action has been initiated to address reported issue.A customer letter will be send regarding the reported issue.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 has been reported that the inner sterile packaging was found already open during the operation, the doctor used a spare bone cement to complete the operation.No adverse events have been reported as a result of the malfunction.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
REFOBACIN BONE CEMENT R 1X40-3
Type of Device
BONE CEMENT, ANTIBIOTIC
Manufacturer (Section D)
BIOMET FRANCE S.A.R.L.
plateau de lautagne bp75
valence cedex 26903
FR  26903
MDR Report Key10313170
MDR Text Key204953537
Report Number3006946279-2020-00132
Device Sequence Number1
Product Code MBB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 10/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2022
Device Catalogue Number3003940001-3
Device Lot NumberA926BA2506
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age66 YR
Patient Weight70
-
-