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

Catalog Number 4721502084-1

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).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.Investigation results concluded that the product is conform and the root cause is undetermined.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 monomer failed to suck into chamber with polymer that is the monomer was not entering.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The lower cylinder was not well screwed to the upper cylinder, consequently the vacuum did not hold, which caused the monomer failure to enter the cylinder.The review of the device manufacturing quality record indicates that (b)(4) products optipac-s 60 refobacin plus bone cement, reference (b)(4), lot number a727c07085 were manufactured on 05 january 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.No similar complaint has been recorded for optipac-s 60 refobacin plus bone cement, reference (b)(4), lot number a727c07085 within one year.Investigation concluded that the reported event was likely due to handling error.A summary of the investigation was sent to the complainant conveying zimmer biomet conclusions and asking customer to refer to instructions for use.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 monomer was not entering into the cylinder.No adverse event has been reported as a result of the malfunction.

• Brand Name: OPTIPAC-S 60 REFOBACIN PLUS BONE CEMENT
• 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: 8369388
• MDR Text Key: 137379927
• Report Number: 3006946279-2019-00153
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 03599870112250
• UDI-Public: (01)03599870112250
• 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: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 4721502084-1
• Device Lot Number: A727C07085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1