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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
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 05/12/2017
Event Type  Death  
Manufacturer Narrative

(b)(4). Report source- foreign. The event occurred in (b)(4). The product within this report is a combination product. Reserve sample was evaluated under standardized conditions and no failure of the bone cement was found; the product functioned as intended. Investigation results concluded that the reported event was likely due to a known risk, known as implantation syndrome. This risk is addressed in the instructions for use (ifu) of this device. 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 during a procedure, the patient experienced hemodynamic shock and hypotension when the cement was injected into the femur. The surgeon was able to complete the procedure. During post-operative monitoring, patient went in to cardiac arrest, could not be resuscitated, and expired. No further information has been made 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 BONE CEMENT R 1X40G
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 Key7046030
MDR Text Key92537880
Report Number3006946279-2017-00252
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
Device Operator
Device EXPIRATION Date10/31/2019
Device MODEL NumberN/A
Device Catalogue Number3003940001
Device LOT NumberA647BJ2508
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 Manufactured04/18/2017
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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