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

Catalog Number 3035890011

Device Problem Unsealed Device Packaging (1444)

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

Event Date 10/15/2021

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 at opening, the powder bag of the cement was already opened and the powder spilled on the table.To continue the surgery it was opened another cement with the same reference.No adverse events have been reported as a result of the malfunction.

Event Description

It was reported that at opening, the powder bag of the cement was already opened and the powder spilled on the table.To continue the surgery it was opened another cement with the same reference.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.The following section has been updated: b4, g3, g6, h2, h3, h6, h10.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.

• Brand Name: BIOMET BONE CEMENT 1X40G
• 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: 12743362
• MDR Text Key: 279828565
• Report Number: 3006946279-2021-00188
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

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 Operator: Health Professional
• Device Catalogue Number: 3035890011
• Device Lot Number: A637BI1602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/03/2021
• Supplement Dates Manufacturer Received: 03/07/2022
• Supplement Dates FDA Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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