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 Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Unique identifier (udi) # : (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.The device manufacturing quality record could not been reviewed as the lot number was not communicated.With the available information, the exact root cause of the event could not 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.Lot number not communicated.

Event Description

It has been reported that during surgery it was not possible to fill the monomer liquid optipac 40 rbc from the bag.The systems have been thrown away, because of contamination.To complete the procedure refobacin bone cement has been used.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The device will not be returned to the manufacturer.Therefore, it will not be analyzed.The device manufacturing quality record could not been reviewed as the lot number was not communicated.With the available information, the exact root cause of the event could not 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 it was not possible to fill the monomer liquid optipac 40 refobacin bone cement from the bag.The system has been thrown away, because of contamination.To complete the procedure refobacin bone cement has been used.The storage condition of the product is: room temperature : 21°c.The operating room condition: room temperature 21°c.

• 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
• MDR Report Key: 7888609
• MDR Text Key: 120695778
• Report Number: 3006946279-2018-00326
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4720502083-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1