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

Catalog Number 3003940001-3

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

Cmp(b)(4).Report source, foreign - event occurred in (b)(6).5 pictures were received.On the first picture, it can be seen the aluminum pouch with the cement pouch batch number (a925c), which comply with the batch reported in the complaint.The inner pouch sealing is discontinuous and powder leaked.On the 2nd picture, it can be seen the folding box with the batch number (a925ca2503) which comply with the batch reported in the complaint, the aluminium pouch, the monomer ampoule and the patient labels.The inner pouch is not visible but powder is visible.On the 3rd picture, it can be seen the folding box with the batch number (a925ca2503) which comply with the batch reported in the complaint, the aluminium pouch, the monomer ampoule and the patient labels.The inner pouch is not visible.On the 4th picture, it can be seen the aluminum pouch with the cement pouch batch number (a925c), which comply with the batch reported in the complaint.The inner pouch sealing is damaged and seems to be discontinuous on the corner.On the 5th picture, it can be seen the aluminum pouch with the cement pouch batch number (a925c), which comply with the batch reported in the complaint.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 before the operation, the sterile package of bone cement product was inspected and powder leakage was found.When other bone cements were opened, powder leakage was found in the same batch.5 boxes of bone cement of the same batch are impacted.No adverse events have been reported as a result of the malfunction.

• Brand Name: REFOBACIN BONE CEMENT R 1X40-3
• 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: 11221775
• MDR Text Key: 229580636
• Report Number: 3006946279-2021-00005
• 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: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 3003940001-3
• Device Lot Number: A925CA2503
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2021
• 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