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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BC R 1X40 US; BONE CEMENT, ANTIBIOTIC
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BIOMET FRANCE S.A.R.L. REFOBACIN BC R 1X40 US; BONE CEMENT, ANTIBIOTIC Back to Search Results
Catalog Number 110034355
Device Problem Chemical Problem (2893)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/27/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Report source, foreign - event occurred in us.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It has been reported that the cement behavior was different as actual, it was runny# and similar to stryker simplex p.
 
Event Description
It was reported that the cement behavior was different as actual, it was runny and similar to stryker simplex p during surgery.There was delay greater than 40 min.No additional patient consequences were reported.
 
Manufacturer Narrative
(b)(4).An analysis of the product with the same reference and batch number has been made but no problem has been found, the product is conform.(see addi256068) 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 the cement behavior was different as actual, it was runny and similar to stryker simplex p during surgery.There was delay greater than 40 min.No additional patient consequences were reported.
 
Manufacturer Narrative
(b)(4).The device was not returned to the manufacturer.Therefore it could not be analyzed.The review of the device manufacturing quality record indicates that 2923 products refobacin bc r 1x40 us, reference (b)(4), lot number 840dag1904 were manufactured on 04 february 2019.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.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.
 
Manufacturer Narrative
(b)(4).The following sections were updated: b4, g4, g7, h1, h2, h6, h10.2 complaints, this one included, have been recorded on refobacin bc r 1x40 us, reference 110034355, from (b)(6) 2019 to (b)(6) 2020.According to available data, the most probable root cause is undetermined.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 behavior was different as actual, it was runny and similar to stryker simplex p during surgery.There was delay greater than 40 min.No additional patient consequences were reported.
 
Event Description
It was reported that the cement behavior was different as actual, it was runny and similar to stryker simplex p during surgery.There was delay greater than 40 min.No additional patient consequences were reported.
 
Manufacturer Narrative
(b)(4) d11 - list of associated devices: avenir standard stem cemented 3, reference 01.06010.203, batch 2999822.The following sections were updated: b4, d11, g4, g7, h1, h2, h10.The associated product avenir standard stem cemented 3 has been received and analyzed the october 1st, 2020.The analyze shows that there is no link to the subject of the event.The product was intact and conform.This analyzed doesn't help us to find another root cause.According to available data, the most probable root cause is undetermined.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
REFOBACIN BC R 1X40 US
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 Key9773616
MDR Text Key198121999
Report Number3006946279-2020-00023
Device Sequence Number1
Product Code MBB
UDI-Device Identifier00880304990197
UDI-Public0880304990197
Combination Product (y/n)N
PMA/PMN Number
K171540
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2021
Device Catalogue Number110034355
Device Lot Number840DAG1904
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age58 YR
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