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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 Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 06/20/2016
Event Type  Malfunction  
Manufacturer Narrative

This user facility is outside of the united states. The necessary manufacturing history to review was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. Zimmer biomet (b)(4) and package supplier are in the process of initiating modifications.

 
Event Description

It was reported that when box of bone cement was opened, package of powder was leaking. There was no patient involvement and no delay in a procedure as a result of the event.

 
Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. An investigation of the complaint has been performed consisting of a documentary review. The review of manufacturing dhr shows that products were manufactured according to the pre-defined specifications. According to the available data and as the product has not been returned for inspection, the exact root cause of the incident cannot be determined. (b)(4).

 
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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
elisabeth plane
plateau de lautagne bp75
valence cedex 
0334757591
MDR Report Key5809556
MDR Text Key50021583
Report Number3006946279-2016-00247
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeTH
PMA/PMN NumberPK150850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Remedial Action Modification/Adjustment
Type of Report Initial,Followup
Report Date 06/22/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/20/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date08/31/2017
Device MODEL NumberN/A
Device Catalogue Number3003940001
Device LOT NumberA435A10233
OTHER Device ID NumberSEE NARRATIVE IN H10
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 Received11/29/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/23/2015
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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