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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. BIOMET BONE CEMENT R 40X2 BONE CEMENT, ANTIBIOTIC

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BIOMET FRANCE S.A.R.L. BIOMET BONE CEMENT R 40X2 BONE CEMENT, ANTIBIOTIC Back to Search Results
Catalog Number 4035890022
Device Problems Leak/Splash (1354); Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Foreign. The event occured in (b)(6). 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 the inner sterile packaging leaked, allowing the cement to pour out. There is no patient involvement.

 
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Brand NameBIOMET BONE CEMENT R 40X2
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
hélène bataille
plateau de lautagne bp75
valence 26903
FR   26903
0334757591
MDR Report Key7279746
MDR Text Key100527399
Report Number3006946279-2018-00021
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeTH
PMA/PMN NumberK150850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Reporter Occupation
Remedial Action Modification/Adjustment
Type of Report Initial,Followup
Report Date 02/19/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/19/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Device EXPIRATION Date08/31/2020
Device Catalogue Number4035890022
Device LOT NumberA539BL0104
OTHER Device ID NumberSEE H10 NARRATIVE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/09/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/04/2016
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

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