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

Catalog Number 110035373

Device Problem Unsealed Device Packaging (1444)

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

Event Date 09/17/2021

Event Type  malfunction  

Manufacturer Narrative

This is a combination product (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 polymer was leaking from the inner pouch because part of the inner polymer pouch was unsealed.This surgery was finished with backup product.No adverse health consequence has been reported as the result of the malfunction.

Event Description

It was reported, that the polymer was leaking from the inner pouch because part of the inner polymer pouch was unsealed.This surgery was finished with backup product.No adverse health consequence has been reported as the result of the malfunction.

Manufacturer Narrative

This is a combination product (b)(4).This follow-up report is being submitted to relay additional information.Several product pictures have been received and allowed to confirmed the reference and the batch of the product involved through the labels.Moreover, pictures shows two holes on the sealing, which confirms the reported event.The product was returned and lab analysis was performed.The product analysis shows that the returned product is one cement pack.The received product comprises the outer box and the inner cement pouch.On the inner pouch, the left sealing is opened on 1/10 of the length, at the junction with the long sealing.We couldn¿t determine the cause of the event through a visual inspection.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.A complaint extract was done regarding packaging : inner cement pouch open sealing: 3 complaints (3 products), this one included, have been recorded on refobacin bone cement r 1x40 japan, reference 110035373, from 01 jan 2018 to 20 dec 2021.3 complaints (3 products), this one included, have been recorded on refobacin bone cement r 1x40 japan, reference 110035373, batch z41dai2201.The investigation confirmed the reported event however the most likely root cause of the event could not be determined.An 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.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: REFOBACIN BONE CEMENT R 1X40 JP
• Type of Device: BONE CEMENT, ANTIBIOTIC
• 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: 12646078
• MDR Text Key: 276854492
• Report Number: 3006946279-2021-00179
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 110035373
• Device Lot Number: Z41DAI2201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2021
• 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