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

Model Number	4011630001
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 8563987
• Report Number: 3006946279-2019-00247
• Device Sequence Number: 2257871
• Product Code: MBB
• UDI-Device Identifier: 07350023774307
• UDI-Public: (01)07350023774307
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K150850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1