MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. BIOMET BONE CEMENT R 40 -3

Catalog Number 3035890011-3

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).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 reported that the cement envelope was found opened and sterility was lost.No adverse events have been reported as a result of the malfunction.

Event Description

It was reported that the cement envelope was found opened and sterility was lost.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Investigation results concluded that the reported event was due to packaging issue (sealing process).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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, h1, h2, h3, h10.D10 - medical devices: biomet bone cement r 40 -3; item# 3035890011-3; lot# a849ah1704.Biomet bone cement r 40 -3; item# 3035890011-3; lot# a849ah1704.Multiple mdr reports were filed for this event, please see associated reports: 3006946279-2021-00199.3006946279-2021-00073.3006946279-2021-00074.Device analysis: the product was returned and lab analysis was performed.The product analysis shows that: 3035890011-3, a849ah1704, biomet bone cement r 40 -3 the sealing is around 1cm discontinuous at the upper left side of the inner pouch.3035890011-3, a849ah1704, biomet bone cement r 40 -3 the sealing is around 4cm discontinuous at the upper left side of the inner pouch.3035890011-3, a849ah1704, biomet bone cement r 40 -3 the sealing is around 1,5cm discontinuous at the upper left side of the inner pouch.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: BIOMET BONE CEMENT R 40 -3
• Type of Device: BONE CEMENT
• 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: 12950629
• MDR Text Key: 287006780
• Report Number: 3006946279-2021-00199
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/04/2022

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 Expiration Date: 11/30/2023
• Device Catalogue Number: 3035890011-3
• Device Lot Number: A849AH1704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 03/29/2022; 06/16/2022
• Supplement Dates FDA Received: 03/30/2022; 07/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1