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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
Model Number N/A
Device Problem Improper Chemical Reaction (2952)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/31/2019
Event Type  malfunction  
Manufacturer Narrative
(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.
 
Event Description
It was reported that when cementing the acetabulum, the cement did not get stuck in acetabulum.They tried to put it down by hand and pushed on it against the acetabulum but it loosened and came out.Then they mixed another syringe of cement and then it worked as it should with a little difficulty.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It has been reported that when cementing the acetabulum, the cement did not get stuck in acetabulum.They tried to put it down by hand and pushed on it against the acetabulum but it loosened and came out.Then they mixed another syringe of cement and then it worked as it should, with a little difficulty.The cement storage temperature was 20°c, the cement storage humidity was 45 %, the operating room temperature was 20°c.
 
Event Description
It has been reported that when cementing the acetabulum, the cement did not get stuck in acetabulum.They tried to put it down by hand and pushed on it against the acetabulum but it loosened and came out.Then they mixed another syringe of cement and then it worked as it should, with a little difficulty.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The reported event could not be confirmed.The product was returned and the cement seemed homogeneous.A test was performed in the laboratory under standardized conditions and the sample tested did not show any unusual behavior during mixing, application or setting.The review of the device manufacturing quality record indicates that (b)(4) products optipac 40 refobacin bone cement r-3, reference (b)(4), lot number 812ba09170 were manufactured on 23 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.No similar complaint has been recorded for optipac 40 refobacin bone cement r-3, batch 812ba09170, within one year.According to the available data, the exact root cause of the event cannot 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 when cementing the acetabulum, the cement did not get stuck in acetabulum.The users tried to put it down by hand and pushed on it against the acetabulum but it loosened and came out.Then the users mixed another syringe of cement and then it worked as it should, with a little difficulty.The cement storage temperature was 20°c, the cement storage humidity was 45 %, the operating room temperature was 20°c.No known adverse event was reported.
 
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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
MDR Report Key8435582
MDR Text Key139315475
Report Number3006946279-2019-00178
Device Sequence Number1
Product Code MBB
UDI-Device Identifier04040029922347
UDI-Public(01)04040029922347
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 09/11/2019
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 Date09/30/2019
Device Model NumberN/A
Device Catalogue Number4710500394-3
Device Lot Number812BA09170
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/26/2019
Initial Date FDA Received03/20/2019
Supplement Dates Manufacturer Received03/27/2019
04/24/2019
09/10/2019
Supplement Dates FDA Received04/17/2019
05/14/2019
09/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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