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

Catalog Number 4720502083-3

Device Problems Mechanical Problem (1384); Improper Chemical Reaction (2952)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign event occurred in (b)(6).The product was returned and lab analysis was performed.The mixing rod event was not observed on the returned product.A reserve sample from the same lot was evaluated and the reported event on polymerization time was confirmed.Testing was performed under standardized conditions and the sample tested showed that the application phase was in compliance with specification, and the setting phase was too short with respect to the specification.As the cement must be applied during the application phase, and not during the setting phase, the too short polymerization time does not have an impact on the function of the product.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 736ba04790 were manufactured on 20 october 2017.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 complaint events.No other complaint concerning polymerization time has been recorded for optipac 40 refobacin plus bone cement-3, reference 4720502083-3, lot number 736ba04790.This event is a one-off.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 product analysis.The documentary review showed that product was manufactured according to the pre-defined specifications of biomet (b)(4).The product analysis showed that the too short polymerization time does not have an impact on the function of the product.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 surgery, the stirring did not break off and the cement hardened too fast, despite cooling.Another optipac was used.No adverse event has been reported as result of the malfunction.

• Brand Name: OPTIPAC 40 REFOBACIN PLUS BONE CEMENT-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: 8948390
• MDR Text Key: 203887404
• Report Number: 3006946279-2019-00373
• 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: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 4720502083-3
• Device Lot Number: 736BA04790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2017
• 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