MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 1X40-3; BONE CEMENT, ANTIBIOTIC

Catalog Number 3003940001-3

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).The device was not returned to the manufacturer.Therefore it could not be analyzed.The review of the device manufacturing quality record indicates that (b)(4) products refobacin bone cement r 1x40g-3, reference (b)(4), batch 839eag1902 were manufactured on 16 january 2019.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

It was reported that the cement did not mix properly, there were lumps in the cement paste.During mixing spots were observed as if water and oil did not mix.This event involves 2 products.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being filled to relay additional information and corrected information.The device was not returned to the manufacturer.Therefore it could not be analyzed.Reserve sample from the same lot was tested 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.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.2 complaints, this one included, have been recorded on refobacin bone cement r 1x40-3, reference (b)(4), batch 839eag1902 and related to the category "cement paste_consistency".According to available data, root cause of the event was unable to 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 was reported that the cement did not mix properly, there were lumps in the cement paste.During mixing spots were observed as if water and oil did not mix.This event involves 2 products.No adverse events have been reported as a result of the malfunction.

• Brand Name: REFOBACIN BONE CEMENT R 1X40-3
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 9389425
• MDR Text Key: 197786325
• Report Number: 3006946279-2019-00525
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 04040029922569
• UDI-Public: (01)04040029922569
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 3003940001-3
• Device Lot Number: 839EAG1902
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1