MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 1X40G; BONE CEMENT, ANTIBIOTIC

Model Number N/A

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Bradycardia (1751); Foreign Body Reaction (1868)

Event Date 01/11/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a moment after implantation of cement blood pressure suddenly dropped and bradycardia was observed.Later during surgery but after the implantation there was also blood loss.Position during operation - on back, method of implantation - cemented.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The device was not returned to the manufacturer.Therefore it could not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non-conformity has been detected which could be linked to the issue and the root cause could not be determined.This complaint is closed but could be reopened if the product is received later.Please note that bone cement implantation syndrome is a known risk with cement.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

Please refer to report 3006946279-2018-00030.

• Brand Name: REFOBACIN BONE CEMENT R 1X40G
• 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: 7258604
• MDR Text Key: 99587883
• Report Number: 3006946279-2018-00030
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: PK150850
• 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: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 4003940001
• Device Lot Number: A733BA3102
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 78 YR
• Patient Weight: 92