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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 Problem Improper Chemical Reaction (2952)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/15/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).The investigation is in process.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 was reported that the cement showed a very long polymerization time.The polymerization time was 16 min, at room temperature 18° degrees.(according to the instructions for use, at that temperature, the polymerization time had should be 11 min).
 
Event Description
It was reported that the cement showed a very long polymerization time.The polymerization time was 16 min, at room temperature 18° degrees.(according to the instructions for use, at that temperature, the polymerization time had should be 11 min).No known adverse event was reported.
 
Manufacturer Narrative
(b)(4).This follow-up report is being filled to relay additional information.The product was not returned, product analysis can't be performed.However, a retain sample of same batch 817ba09230 has been tested in the laboratory under standardized conditions (23°c; rel.Humid >=40 %).No unusual behaviour during mixing, handling or setting was noticed.The reported behaviour of the cement cannot be reproduced the review of the device manufacturing quality record indicates that (b)(4) products optipac 40 refobacin plus bone cement-3, reference (b)(4), batch 817ba09230 were manufactured on 05th june 2018.No other similar complaint has been recorded over the batch 817ba09230 within one year.According to available data, the exact root cause can¿t 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.
 
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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 Key8550333
MDR Text Key145117864
Report Number3006946279-2019-00249
Device Sequence Number1
Product Code MBB
UDI-Device Identifier04040029922354
UDI-Public(01)04040029922354
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 09/16/2019
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 Date11/30/2019
Device Catalogue Number4720502083-3
Device Lot Number817BA09230
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/15/2019
Initial Date FDA Received04/25/2019
Supplement Dates Manufacturer Received09/12/2019
Supplement Dates FDA Received09/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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