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

Model Number N/A

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

Cmp-(b)(4).Concomitant medical products - medical devices: biomet bone cement r 40 -3; item# 3035890011-3; lot# a849ah1704 biomet bone cement r 40 -3; item# 3035890011-3; lot# a849ah1704.Report source: foreign:(b)(4).Multiple mdr reports were filed for this event, associated reports: multiple mdr reports were filed for this event, associated reports: 3006946279-2021-00199, 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

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.

• 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: 14998133
• MDR Text Key: 295864587
• Report Number: 3006946279-2022-00073
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 00887868358319
• UDI-Public: (01)00887868358319(17)231130(10)A849AH1704
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Other
• Type of Report: Initial
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 3035890011-3
• Device Lot Number: A849AH1704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2022
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1