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

Catalog Number 4710500394-3

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, [product was discarded].The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported that during surgery the cement harden time of the optipac refobacin bone cement varies from just a few minutes to 20 minutes, although the products are stored to room temperature and placed one next to each other.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following section has been updated : d2, g1-2, g4, h1/h2/h3, h6, h10.The product analysis can't be performed as the product was not returned.The documentary review showed that products were manufactured according to the pre-defined specifications of biomet france.A retain sample of batch involved in this complaint has been tested in the laboratory under standardized conditions (23°c; rel.Humid >=40 %).No unusual behavior during mixing, handling or setting.The reported behaviour of the cement cannot be reproduced.As explained in the ifu, the working time and the rate of polymerization are strongly dependent on ambient temperature and temperature of the components.The hardening time is shorter at high temperatures and longer at low temperatures.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 has been reported that during surgery the cement harden time of the optipac refobacin bone cement varies from just a few minutes to 20 minutes, although the products are stored to room temperature and placed one next to each other.

• Brand Name: OPTIPAC 40 REFOBACIN BONE CEMENT R-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
• MDR Report Key: 8369293
• MDR Text Key: 137138878
• Report Number: 3006946279-2019-00149
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 04040029922347
• UDI-Public: (01)04040029922347
• Combination Product (y/n): N
• PMA/PMN Number: K171540
• 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: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 4710500394-3
• Device Lot Number: 811AA09170
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/26/2019
• Supplement Dates Manufacturer Received: 07/18/2019
• Supplement Dates FDA Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1