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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN PLUS BONE CEMENT 40 BONE CEMENT, ANTIBIOTIC

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BIOMET FRANCE S.A.R.L. REFOBACIN PLUS BONE CEMENT 40 BONE CEMENT, ANTIBIOTIC Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 07/26/2017
Event Type  Death  
Manufacturer Narrative

(b)(4). Multiple mdr's were submitted for this event. Please see reports: 3006946279 - 2017 - 00253, 3006946279 - 2017 - 00254, 3006946279 - 2017 - 00255. (b)(4). Concomitant products: 3020830401, refobacin plus bone cement 40 , qty 4, lots: a642bj2508, a651cj1703, a644bj2507, a705ak0104. Report source- foreign. The event occurred in (b)(4). The product within this report is a combination product. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned to manufacturer.

 
Event Description

It was reported that during a procedure, the patient experienced decrease in blood pressure as the prosthesis was cemented. The surgery was ended by closing the arthrotomy. The patient was transferred to the intensive care unit where a cardiac ultrasound showed evidence of a cement embolism. Despite the reanimation measures taken, the patient expired. No further information is available at this time.

 
Manufacturer Narrative

(b)(4). An investigation has been performed, consisting of a product analysis and a documentary review. The documentary review showed that products were manufactured according to the pre-defined specifications of biomet (b)(4). Product analysis on retained samples from the same batch showed no unusual behaviour during mixing, handling or setting. The most probable reason for death is the cement implantation syndrome. This risk is described in the ifu provided with the product. No non-conformity has been detected concerning the products.

 
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Brand NameREFOBACIN PLUS BONE CEMENT 40
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
helene bataille
plateau de lautagne bp75
valence cedex, IN 26903
FR   26903
5745273773
MDR Report Key7046629
MDR Text Key92555250
Report Number3006946279-2017-00256
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberPK150850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation PHARMACIST
Type of Report Initial,Followup
Report Date 02/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/20/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date01/31/2020
Device MODEL NumberN/A
Device Catalogue Number3020830401
Device LOT NumberA705AK0104
OTHER Device ID NumberSEE H10 NARRATIVE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/17/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 11/20/2017 Patient Sequence Number: 1
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