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 1X40G; 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 1X40G; BONE CEMENT, ANTIBIOTIC Back to Search Results
Catalog Number 3003940001
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/19/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Report source, foreign - event occurred in (b)(6).The device was not returned to the manufacturer.Therefore it could not be analyzed.The review of the device manufacturing quality record indicates that 5035 products designation refobacin bone cement r 1x40g, reference (b)(4), lot number a747da1505 were manufactured on 19 april 2018.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.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.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 the inner sterile packaging in the side of d is opened.Event occurred before initial surgery.One product was involved in the event.There was no patient involvement.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.Pictures were received and reviewed.The picture review shows that the inner cement pouch was opened.The reported event could be confirmed.The review of the device manufacturing quality record indicates that (b)(4) designation refobacin bone cement r 1x40g, reference 3003940001, lot number a747da1505 were manufactured on 19 april 2018.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.6 similar complaints (including the current complaint) have been recorded for refobacin bone cement r 1x40g reference 3003940001, lot number a747da1505 on the reported event within one year.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.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 the inner sterile packaging in the side of d is opened.Event occurred before initial surgery.One product was involved in the event.There was no patient involvement.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 1X40G
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 Key9314808
MDR Text Key191105015
Report Number3006946279-2019-00470
Device Sequence Number1
Product Code MBB
Combination Product (y/n)N
PMA/PMN Number
K150850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 12/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2020
Device Catalogue Number3003940001
Device Lot NumberA747DA1505
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-