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

Catalog Number 110035373

Device Problem Unsealed Device Packaging (1444)

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

Event Date 08/25/2021

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.The surgery was finished with backup product.No adverse event has been reported as the result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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.The surgery was finished with backup product.No adverse event has been reported as the result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Two pictures have been received.The first picture received shows the patient labels with the product reference and batch.The second picture shows the inner cement pouch with a corner of the sealing opened.Therefore, the reported event is confirmed.The product was returned and lab analysis was performed (see details in pce).The product analysis shows that the return product is one cement pack which comprises the outer box, the inner cement pouch, the monomer pouch and the patient labels.The inner pouch sealing is opened at both top and bottom of the pouch, allowing the cement to leak out.Therefore, the reported event is confirmed.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.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.A complaint extract was done regarding inner cement pouch open sealing: 21 complaints (21 products), this one included, have been recorded on the brand cement pack soft pouch, all references included, to date (january 07, 2022) 3 complaints (3 products), this one included, have been recorded on refobacin bone cement r 1x40 -3, reference 110035373, batch z41dai2201.According to available data, root cause of the event was unable to be determined.However, a scar (scar-03110) has been initiated in order to deeper investigate the cause of the event with the cement pouch supplier osartis 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.

Event Description

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

• Brand Name: REFOBACIN BONE CEMENT R 1X40 JP
• Type of Device: BONE CEMENT, ANTIBIOTICS
• 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: 12604891
• MDR Text Key: 277363435
• Report Number: 3006946279-2021-00169
• 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,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2022
• 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