MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 60 -3; BONE CEMENT, ANTIBIOTIC

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source- foreign.The event occurred in (b)(6).The product within this report is a combination product.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the inner sterile packaging was compromised, allowing the cement powder contents to leak out.No further information has been made available at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Corrective action has been initiated for the reported issue.The device will not be returned to the manufacturer.Therefore it will not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.Corrective action has been initiated to address reported issue.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 inner sterile packaging was compromised, allowing the cement powder contents to leak out.No further information has been made available at this time.

• Brand Name: REFOBACIN BONE CEMENT R 60 -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
• 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: 7147285
• MDR Text Key: 96054784
• Report Number: 3006946279-2017-00298
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K171540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 3003960001-3
• Device Lot Number: 603ACE1704
• Other Device ID Number: (01)4040029922613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1