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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIP 60 REFOBACIN PLUS BONE CMT-3; BONE CEMENT, ANTIBIOTIC
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BIOMET FRANCE S.A.R.L. OPTIP 60 REFOBACIN PLUS BONE CMT-3; BONE CEMENT, ANTIBIOTIC Back to Search Results
Catalog Number 4721502084-3
Device Problem Improper Chemical Reaction (2952)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/19/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Report source, foreign - event occurred in (b)(6).The review of the device manufacturing quality record indicates that (b)(4) products optipac 60 refobacin plus bone cement-3, reference 4721502084-3, lot number 844ac02045 were manufactured on 03 december 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.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the cement shipped in the same shipment showed a very short polymerization time.Storage condition of the product : humidity (%) nearly 50%.Operating room condition : higher than 25 °c.2 products were affected by the issue and another product was used to complete the surgery.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 returned device was evaluated.Two products with the same batch number were returned in their original blister.The returned products can¿t confirm the reported event.However, reserve sample from the same lot was tested under standardized conditions.The product did not show any unusual behavior during mixing, handling or setting.The reported behavior of the cement could not be reproduced.The review of the device manufacturing quality record indicates that (b)(4) products optipac 60 refobacin plus bone cement-3, reference (b)(4), lot number 844ac02045 were manufactured on 03 december 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 other similar complaint has been recorded for optipac 60 refobacin plus bone cement-3, reference (b)(4), lot number 844ac02045 on the reported event within one year.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 was reported that the cement shipped in the same shipment showed a very short polymerization time.Storage condition of the product : humidity (%) nearly 50%.Operating room condition : higher than 25 °c.2 products were affected by the issue and another product was used to complete the surgery.No adverse events have been reported as a result of the malfunction.
 
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Brand Name
OPTIP 60 REFOBACIN PLUS BONE CMT-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 Key9207712
MDR Text Key218501776
Report Number3006946279-2019-00427
Device Sequence Number1
Product Code MBB
UDI-Device Identifier04040029922378
UDI-Public(01)04040029922378
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
Report Date 12/06/2019
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 Date05/31/2020
Device Catalogue Number4721502084-3
Device Lot Number844AC02045
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/02/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/19/2019
Initial Date FDA Received10/18/2019
Supplement Dates Manufacturer Received12/05/2019
Supplement Dates FDA Received12/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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