MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 80 REFOBACIN BONE CEMENT R BONE CEMENT, ANTIBIOTIC

Catalog Number 4712500398-3

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 07/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4). Foreign report source: (b)(6). The device will not be returned to the manufacturer. Therefore it will not be analyzed. The device manufacturing quality record indicates that the released product met all requirements to perform as intended. The investigation is in progress. Once the investigation has been completed, a follow-up mdr will be submitted. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

It was been reported that during tha revision surgery, the patient had cardiac arrest during provisional reduction after cement hardening. Immediately after resuscitation, the condition became stable after 30 minutes.

• Brand Name: OPTIPAC 80 REFOBACIN BONE CEMENT R
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10366793
• MDR Text Key: 201677940
• Report Number: 3006946279-2020-00150
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (Y/N): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: FOREIGN,HEALTH PROFESSIONAL

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/05/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 4712500398-3
• Device LOT Number: A948CE1501
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/29/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 12/19/2019
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Invalid Data
• Removal/Correction Number: N/A

Patient TREATMENT DATA

Date Received: 08/05/2020 Patient Sequence Number: 1