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

Catalog Number 3003940001

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).The device has been returned to the manufacturer.The device analysis is ongoing.The review of the device manufacturing quality record indicates that 5 173 products refobacin bone cement r 1x40g, reference (b)(4), batch a744ec2204 were manufactured on 10th july 2018.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.According to available data, the most probable root cause is due to packaging issue (sealing process).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 was reported that upon opening the cement, powder was bursted.The surgery was completed with another product.No adverse events have been reported as a result of the malfunction.

Event Description

It was reported that upon opening the cement, powder was bursted.The surgery was completed with another product.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4) g3 - report source, foreign - event occurred in south korea.This follow-up report is being submitted to relay additional information.The following sections were updated: h2, h6, h10.Complaint sample was evaluated and the reported event was confirmed.Evaluation of returned device found that the sealing was opened on one side.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.Within one year, no similar complaint has been recorded for biomet bone cement 1x40g, batch a744ec2204.According to available data, the most probable root cause is due to packaging issue (sealing process).Corrective action has been initiated to address reported issue.A summary of the investigation has been sent to the complainant.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.

• Brand Name: REFOBACIN BONE CEMENT R 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
• MDR Report Key: 9472767
• MDR Text Key: 197804299
• Report Number: 3006946279-2019-00490
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: K150850
• 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: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 3003940001
• Device Lot Number: A744EC2204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1