MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN REVISION 1X40G; BONE CEMENT, ANTIBIOTIC

Model Number 4011630001

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The device manufacturing quality record review did not show any non-conformity or deviation related to the described event.A sample of the same lot number has been analyzed in the laboratory under standardized conditions.The product did not show any unusual behavior during mixing, handling or setting.The reported behavior of the cement could not be reproduced.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.

Event Description

It has been reported that the cement was not solidified for 30 minutes during the surgery.The event occured on two cements of same reference and same batch.

• Brand Name: REFOBACIN REVISION 1X40G
• Type of Device: BONE 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: christina arnt ; 56 e, bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8563987
• MDR Text Key: 143573804
• Report Number: 3006946279-2019-00247
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 07350023774307
• UDI-Public: (01)07350023774307
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 4011630001
• Device Catalogue Number: 4011630001
• Device Lot Number: A743DC2204
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1