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 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

This is a combination product.(b)(4).Report source, foreign - event occurred in (b)(6).Pictures have been received.The reported event was confirmed as it can be seen that the inner cement pouch sealing is damaged and that cement powder leaked outside the inner pouch.The product analysis can't be performed as the product was not returned.The complaint is related to a well-known event, previously evaluated and investigated.No further investigation is required as per 21 cfr part 820.198 complaint files §(b) and (c).Investigation results concluded that the reported event was due to packaging issue (sealing process).Corrective action has been initiated to address reported issue.A summary of the investigation was sent to the complainant conveying zimmer biomet conclusions.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 a pre-operative examination of bone cement revealed powder leakage from the inner cement pouch.As reported the product will no be returned due to customs regulations.In addition it was reported that no patient was involved.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: 12411930
• MDR Text Key: 269533770
• Report Number: 3006946279-2021-00148
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/02/2021

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 Expiration Date: 05/05/2022
• Device Catalogue Number: 3003940001-3
• Device Lot Number: A925CA2503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2019
• 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