MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. BIOMET BONE CEMENT R 40X2; BONE CEMENT, ANTIBIOTIC

Model Number N/A

Device Problems Leak/Splash (1354); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The product within this report is a combination product.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Other not returned to manufacturer.

Event Description

It was reported the cement inner sterile packaging was ripped, allowing the cement powder to pour out.No patient consequences or additional information were reported.

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Evaluation of returned device found the supplier sealing was opened in 2 areas.The manufacture sealing was intact.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to product design issue.Corrective action has been initiated to address reported issue.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 3006946279-2017-00278.

• Brand Name: BIOMET BONE CEMENT R 40X2
• 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: hélène bataille ; plateau de lautagne bp75; valence, IN 26903 ; FR 26903 ; 5745273773
• MDR Report Key: 7096486
• MDR Text Key: 95081823
• Report Number: 3006946279-2017-00278
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: PK150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 4035890022
• Device Lot Number: A609AF1307
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1