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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 40 REFOBACIN PLUS BONE CEMENT-3; BONE CEMENT, ANTIBIOTIC
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BIOMET FRANCE S.A.R.L. OPTIPAC 40 REFOBACIN PLUS BONE CEMENT-3; BONE CEMENT, ANTIBIOTIC Back to Search Results
Catalog Number 4720502083-3
Device Problems Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/15/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).The device will not be returned to the manufacturer.Therefore it will not be analyzed.The device manufacturing quality record could not been reviewed as the lot number was not communicated.With the available information, the exact root cause of the event could not be determined.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 during surgery it was not possible to empty the monomer liquid from the bag.The systems has been thrown away because of contamination.To complete the procedure refobacin bone cement has been used.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The device will not be returned to the manufacturer.Therefore it will not be analyzed.The device manufacturing quality record could not been reviewed as the lot number was not communicated.With the available information, the exact root cause of the event could not be determined.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 during surgery it was not possible to empty the monomer liquid from the bag.The systems has been thrown away because of contamination.To complete the procedure refobacin bone cement has been used.The storage condition of the product is : room temperature 20°c.The operating room condition is : room temperature 20°c.
 
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Brand Name
OPTIPAC 40 REFOBACIN PLUS BONE CEMENT-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 Key7880602
MDR Text Key120397191
Report Number3006946279-2018-00320
Device Sequence Number1
Product Code MBB
Combination Product (y/n)N
PMA/PMN Number
PK171540
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 06/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number4720502083-3
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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