MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 60 REFOBACIN BONE CEMENT R-3; BONE CEMENT , ANTIBIOTIC

Catalog Number 4711500396-3

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not be returned to the manufacturer.Therefore it was not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.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.

Event Description

It has been reported that it took more than 16 minutes for the bone cement to harden.

Event Description

It has been reported that it took more than 16 minutes for the bone cement to harden.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reserve sample from the same lot than the product involved in the complaint was evaluated, and showed no abnormal behavior.The reported event was unconfirmed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.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.

• Brand Name: OPTIPAC 60 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: 8353976
• MDR Text Key: 136847612
• Report Number: 3006946279-2019-00110
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 04040029922361
• UDI-Public: (01)04040029922361
• 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
• Type of Report: Initial,Followup
• Report Date: 05/22/2019

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: 05/31/2018
• Device Catalogue Number: 4711500396-3
• Device Lot Number: 636AA05105
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/20/2019
• Supplement Dates Manufacturer Received: 05/22/2019
• Supplement Dates FDA Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1