MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. BIOMET BONE CEMENT R 1X40 US

Model Number 110035368

Device Problem Unsealed Device Packaging (1444)

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

Event Date 10/25/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 sterile cement package was opened inside of unsterile outer package.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 product was returned and lab analysis was performed.The product analysis shows that the inner pouch sealing is damaged.The reported event is confirmed.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 sterile cement package was opened inside of unsterile outer package.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 product was returned and lab analysis was performed.The product analysis shows that the inner pouch sealing is damaged.The reported event is confirmed.Investigation results concluded that the reported event was due to packaging 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

It was reported that the sterile cement package was opened inside of unsterile outer package.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.This follow-up report is being submitted to relay corrected information.The product was returned and lab analysis was performed.The product analysis shows that the inner pouch sealing is damaged.The reported event is confirmed.Investigation results concluded that the reported event was due to packaging issue.A definitive root cause cannot be determined.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

It was reported that the sterile cement package was opened inside of unsterile outer package.No adverse events have been reported as a result of the malfunction.

• Brand Name: BIOMET BONE CEMENT R 1X40 US
• 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: 12828687
• MDR Text Key: 282906399
• Report Number: 3006946279-2021-00196
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 00887868214578
• UDI-Public: 00887868214578
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172408
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/13/2022

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 Model Number: 110035368
• Device Catalogue Number: 110035368
• Device Lot Number: AZ40BI1806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 11/25/2021; 03/23/2022; 04/13/2022
• Supplement Dates FDA Received: 12/13/2021; 03/30/2022; 04/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2021
• 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