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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 80 REFOBACIN BONE CEMENT R; BONE CEMENT, ANTIBIOTIC
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BIOMET FRANCE S.A.R.L. OPTIPAC 80 REFOBACIN BONE CEMENT R; BONE CEMENT, ANTIBIOTIC Back to Search Results
Catalog Number 4712500398-3
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cardiac Arrest (1762)
Event Date 07/09/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Foreign report source: (b)(6).The device will not be returned to the manufacturer.Therefore it will not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.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 been reported that during tha revision surgery, the patient had cardiac arrest during provisional reduction after cement hardening.Immediately after resuscitation, the condition became stable after 30 minutes.
 
Manufacturer Narrative
(b)(4).The medical record has not been received, therefore, the reported event could not be confirmed.The product analysis can't be performed as the product was not returned.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.The instructions for use have been reviewed and it was noticed that there is warning regarding cardiac arrest in side effects section.It can be notice that the patient suffer from arrhythmia, that might explain the cardiac arrest during the surgery.A complaint extract was done regarding bone cement implantation syndrom: 1 complaint (1 product), this one included, has been recorded on optipac 80 refobacin bone cement r, reference 4712500398-3, from january 01, 2017 to october 16, 2020.1 complaint (1 product), this one included, has been recorded on optipac 80 refobacin bone cement r, reference 4712500398-3, batch a948ce1501.According to available data, root cause of the event might be the patient condition as it is mentioned that she suffer from arrhythmia.A summary of the investigation has been sent to the customer.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 been reported that during tha revision surgery, the patient had cardiac arrest during provisional reduction after cement hardening.Immediately after resuscitation, the condition became stable after 30 minutes.
 
Event Description
It was been reported that during tha revision surgery, the patient had cardiac arrest during provisional reduction after cement hardening.Immediately after resuscitation, the condition became stable after 30 minutes.
 
Manufacturer Narrative
(b)(4).This follow-up report is being filled to relay additional information.The medical record has not been received, therefore, the reported event could not be confirmed.The product analysis can't be performed as the product was not returned.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.The instructions for use have been reviewed and it was noticed that there is warning regarding cardiac arrest in side effects section.It can be notice that the patient suffer from arrhythmia, that might explain the cardiac arrest during the surgery.A complaint extract was done regarding bone cement implantation syndrom: 1 complaint (1 product), this one included, has been recorded on optipac 80 refobacin bone cement r, reference 4712500398-3, from january 01, 2017 to october 16, 2020.1 complaint (1 product), this one included, has been recorded on optipac 80 refobacin bone cement r, reference 4712500398-3, batch a948ce1501.According to available data, root cause of the event might be the patient condition as it is mentioned that she suffer from arrhythmia.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 80 REFOBACIN BONE CEMENT R
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 Key10366793
MDR Text Key201677940
Report Number3006946279-2020-00150
Device Sequence Number1
Product Code MBB
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
Report Date 11/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/31/2021
Device Catalogue Number4712500398-3
Device Lot NumberA948CE1501
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Weight50
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