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

Catalog Number 110034355

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

This is a combination product (b)(4).Event occurred in united states.The device was not returned to the manufacturer.Therefore, it could not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No available photos have been provided by the customer which confirm the issue, but the received picture with the labels confirms the references of the two involved products.1 complaint (1 product), this one included, has been recorded on refobacin bone cement r 1x40 us, reference 110034355, batch 840cag1903 since ever.According to available data, the root cause 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 cement would not mix and the powder was still present.It was also reported later, that the paste had clumps so the consistency failed during the mixing process (stryker advanced mixing system).Another cement was prepared and surgery was finished.No adverse events have been reported as a result of the malfunction.

• Brand Name: REFOBACIN BC R 1X40 US
• 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: 12258918
• MDR Text Key: 264492057
• Report Number: 3006946279-2021-00125
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 00880304990197
• UDI-Public: 0880304990197
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/02/2021

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: 09/30/2021
• Device Catalogue Number: 110034355
• Device Lot Number: 840CAG1903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2021
• Initial Date FDA Received: 08/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• 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