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

Catalog Number 110035372

Device Problem Unsealed Device Packaging (1444)

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

Event Date 07/28/2021

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 has been reported that the polymer was leaking from the inner pouch because part of the inner polymer pouch was unsealed.As reported, the surgery was finished with backup product.No adverse event has been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No further information provided (x-rays, surgical report, photographs, lab test).The device manufacturing quality record indicates that the released product met all requirements to perform as intended.A complaint extract was done regarding packaging : inner_cement_pouch_open_sealing: - to date (13-oct-2021) 12 complaints (involving 12 products), this one included, have been recorded on biomet bone cement r 1x40 jp, reference 110035372, since ever.- 8 complaints (involving 8 products), this one included, have been recorded on biomet bone cement r 1x40 jp, reference 110035372, batch z34eaf1509, since ever.The product involved in the reported event was not able to be inspected as it was not returned (discarded at the hospital).A sealing force test has been performed on a product received from a similar complaint ((b)(4)- same item reference) and showed that the pouch sealing force a was compliant with zimmer biomet valence specification.Investigation results concluded that the reported event was due to manufacturing (sealing process).A corrective action has been initiated in order to deeper investigate the cause of the event with the cement pouch supplier and to consider to implement actions to avoid the recurrence of this type of issue.The complaint is closed but could be reopened if new information is received later.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 has been reported that the polymer was leaking from the inner pouch because part of the inner polymer pouch was unsealed.As reported, the surgery was finished with backup product.No adverse event has been reported as a result of the malfunction.

• Brand Name: BIOMET BONE CEMENT R 1X40 JP
• Type of Device: BONE CEMENT
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 12352480
• MDR Text Key: 268900903
• Report Number: 3006946279-2021-00136
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 110035372
• Device Lot Number: Z34EAF1509
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1