MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BONE CEMENT R 1X40-3; BONE CEMENT, ANTIBIOTIC

Catalog Number 3003940001-3

Device Problem Unsealed Device Packaging (1444)

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

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

This is a combination product.(b)(4).Report source, foreign - event occurred in (b)(6).The device manufacturing quality record indicates that the released product met all requirements to perform as intended.One picture was received but the reported event could not be confirmed on the basis of that picture.The product analysis was not able to be performed as the product was not returned.A complaint extract was done regarding packaging : inner_cement_pouch_open_sealing: 54 complaints (involving 155 products), this one included, have been recorded on refobacin bone cement r 1x40-3, reference 3003940001-3, from 01-jan-2018 to 28-jul-2021.1 complaint (involving 2 products), this one included, has been recorded on refobacin bone cement r 1x40-3, reference 3003940001-3, batch z18aag0103, since ever.So this is a single event for this product lot.The reported event was not able to be confirmed as the product was not returned and no picture showing the reported event was available.Therefore, the root cause of the event was unable to be determined.Regarding the inner cement pouch open sealing issues, these are well-known events, previously evaluated and investigated.No further investigation is required as per 21 cfr part 820.198 complaint files §(b) and (c).And a corrective action has been initiated to address this issue.A summary of the investigation has been sent to the customer.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, during the surgery, the inner sterile packaging was found opened.In addition it was reported that the doctor used a new product to complete the surgery.The product cannot be returned to france, as it does not comply customs regulations.No adverse event has been reported as a result of the malfunction.

• Brand Name: REFOBACIN BONE CEMENT R 1X40-3
• 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: 12245337
• MDR Text Key: 266164852
• Report Number: 3006946279-2021-00120
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 3003940001-3
• Device Lot Number: Z18AAG0103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2020
• 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
• Patient Age: 65 YR