MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 40 REFOBACIN PLUS BONE CEMENT-3

Model Number N/A

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign ¿ event occurred in (b)(6).The device will not be returned to the manufacturer.Therefore, it will 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 review of the device manufacturing quality record indicates that (b)(4) products optipac 40 refobacin plus bone cement-3, reference 4720502083-3, lot number 817ba08660 were manufactured on 04 june 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 other complaint has been recorded for optipac reference 4720502083-3, lot number 817ba08660 on the reported event within one year.With the available information, the exact root cause of the event could not be determined.An investigation has been performed, consisting of a documentary review and a reserve sample analysis.The documentary review showed that product was manufactured according to the pre-defined specifications of biomet france.The reserve sample analysis did not show any unusual behavior during mixing, handling or setting.According to available data, the exact root cause can¿t 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 during a surgery, the cement consistency was more solid after the mixing process than usual.The monomer has been completely entered in the cylinder and the mixing process has been performed as usual.There was no patient adverse consequences.

• Brand Name: OPTIPAC 40 REFOBACIN PLUS BONE CEMENT-3
• Type of Device: OPTIPAC
• 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: 9238731
• MDR Text Key: 196419568
• Report Number: 3006946279-2019-00421
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 4720502083-3
• Device Lot Number: 817BA08660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 10/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2018
• 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