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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.

 
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Brand NameOPTIPAC 80 REFOBACIN BONE CEMENT R
Type of DeviceBONE CEMENT, ANTIBIOTIC
Manufacturer (Section D)
BIOMET FRANCE S.A.R.L.
plateau de lautagne bp75
valence cedex 26903
FR 26903
Manufacturer (Section G)
BIOMET FRANCE S.A.R.L.
plateau de lautagne bp75
valence cedex 26903
FR 26903
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key10366793
MDR Text Key201677940
Report Number3006946279-2020-00150
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
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 Catalogue Number4712500398-3
Device LOT NumberA948CE1501
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/29/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/19/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 08/05/2020 Patient Sequence Number: 1
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