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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 BONE CEMENT R-3; BONE CEMENT, ANTIBIOTIC
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BIOMET FRANCE S.A.R.L. OPTIPAC 40 REFOBACIN BONE CEMENT R-3; BONE CEMENT, ANTIBIOTIC Back to Search Results
Catalog Number 4710500394-3
Device Problem Chemical Problem (2893)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2021
Event Type  malfunction  
Manufacturer Narrative
This is a combination product (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.
 
Event Description
It was reported that shortly after bringing the two components together, the cement immediately became hard.It was no longer possible to finish the mixing process.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 manufacturing quality record indicate that the released product met all requirements to perform as intended.Complaint history identified no additional complaints for the reported part/lot combination.A definitive root cause cannot be determined.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 shortly after bringing the two components together, the cement immediately became hard.It was no longer possible to finish the mixing process.No adverse events have been reported as a result of the malfunction.
 
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Brand Name
OPTIPAC 40 REFOBACIN BONE CEMENT R-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
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 Key12958978
MDR Text Key283404353
Report Number3006946279-2021-00204
Device Sequence Number1
Product Code MBB
Combination Product (y/n)N
Reporter Country CodeGM
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 04/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2022
Device Catalogue Number4710500394-3
Device Lot NumberAZ37AH1301
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/01/2021
Initial Date FDA Received12/08/2021
Supplement Dates Manufacturer Received04/04/2022
Supplement Dates FDA Received04/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/21/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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