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

Model Number N/A

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported refobacin harden after 20 minutes, although it has been stored at 22 °c and the surgery room temperature was at 21 °c.

Event Description

It was reported refobacin harden after 20 minutes, although it has been stored at 22 °c and the surgery room temperature was at 21 °c.No known adverse event was reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The product was returned and analysed.The cement is homogeneous and has been used.A product analysis was performed on an another product of the same reference and batch retained at zimmer biomet facilities.This analysis show that the cement behavior was in compliance with the specifications.The reported event is not confirmed.The review of the device manufacturing quality record indicates that 1805 products optipac 40 refobacin bone cement r-3, reference: (b)(4), lot number: 812ba08670 were manufactured on 09 may 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.2 complaints have been recorded for optipac 40 refobacin bone cement r-3, batch: 812ba08670 within one year.According to available data, the exact root cause can¿t be determined.A summary of the investigation has been sent to the complainant.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.

• 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: 8344163
• MDR Text Key: 136912987
• Report Number: 3006946279-2019-00119
• 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
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

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: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 4710500394-3
• Device Lot Number: 812BA08670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/15/2019
• Supplement Dates Manufacturer Received: 01/20/2019
• Supplement Dates FDA Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1