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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. NOT COMMUNICATED

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BIOMET FRANCE S.A.R.L. NOT COMMUNICATED Back to Search Results
Catalog Number NOT COMMUNICATED
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (b)(6). The device was not evaluated as the batch number was not communicated and the product was not returned. The device will not returned to the manufacturer. Therefore it could not be analyzed. The device manufacturing quality record could not be reviewed as the item and lot number of the product were not communicated. With the available information, the exact root cause of the event could not be determined. 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 has been reported that the monomer was not entering into the cement system.
 
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Brand NameNOT COMMUNICATED
Type of DeviceNOT COMMUNICATED
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 Key8357541
MDR Text Key137316392
Report Number3006946279-2019-00109
Device Sequence Number1
Product Code JDY
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/29/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNOT COMMUNICATED
Device Lot NumberNOT COMMUNICATED
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 Received08/28/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/27/2017
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

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