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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 1X40G; BONE CEMENT, ANTIBIOTIC
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BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 1X40G; BONE CEMENT, ANTIBIOTIC Back to Search Results
Catalog Number 3003940001
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/25/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Report source, foreign - event occurred in (b)(6).The device was not returned to the manufacturer.Therefore it could not be analyzed.The review of the device manufacturing quality record indicates that (b)(4) products refobacin bone cement r 1x40g, reference 3003940001, lot number a749dc0513 were manufactured on 17 may 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.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.According to available data, the most probable root cause is due to packaging issue (sealing process).Corrective action has been initiated to address reported issue.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 inner sterile packaging was found opened during the operation, spare bone cement was used to complete the operation.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 following sections were updated: b4, g4, h2, h6, h10 the reported event was confirmed by review of pictures.The device was not be returned to the manufacturer.Therefore it could not be analyzed.The review of the device manufacturing quality record indicates that 3 231 products refobacin bone cement r 1x40g, reference 3003940001, lot number a749dc0513 were manufactured on 17 may 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.22 similar complaints have been recorded for refobacin bone cement r reference (b)(4), batch a749dc0513 within one year.According to the available data, the most probable root cause is due to packaging issue (sealing process).Corrective action has been initiated to address reported issue.A summary of the investigation was sent to the complainant conveying zimmer biomet conclusions (to remove if no letter was sent) 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 inner sterile packaging was found opened during the operation, spare bone cement was used to complete the operation.No adverse events have been reported as a result of the malfunction.
 
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Brand Name
REFOBACIN BONE CEMENT R 1X40G
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 Key9471888
MDR Text Key215115082
Report Number3006946279-2019-00549
Device Sequence Number1
Product Code MBB
Combination Product (y/n)N
PMA/PMN Number
K150850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 01/07/2020
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 Date11/30/2020
Device Catalogue Number3003940001
Device Lot NumberA749DC0513
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/28/2019
Initial Date FDA Received12/16/2019
Supplement Dates Manufacturer Received01/07/2020
Supplement Dates FDA Received01/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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