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

Catalog Number 110034355

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned to the manufacturer.Therefore it could not be analyzed.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 bone cement texture was airy.This cement was used on multiple cases, this was account owned and they want a credit and one for one replacement for each type of cement.This issue concerns 89 products.No adverse event was reported.

Event Description

It was reported that bone cement was impossible to open texture was liked whipped butter "fluffy".This reports investigates cement paste consistency, however returned products showed packaging issues.This issue concerns 89 products.No adverse event was reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following section has been updated : b4, b5, d10, g4, g7, h1, h2, h6, h10.The product was returned and lab analysis was performed, showing a packaging difficult to open.An analysis on a retained sample from the same batch has been done and the cement is conform for cement paste consistency.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.(b)(4) complaint, this one included, have been recorded over the batch 835aae2507 for cement paste consistency.With the available information, the exact root cause of the event could not be determined.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 BC R 1X40 US
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 9537557
• MDR Text Key: 219594050
• Report Number: 3006946279-2019-00557
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 00880304990197
• UDI-Public: 0880304990197
• Combination Product (y/n): N
• PMA/PMN Number: K151540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

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: 07/31/2021
• Device Catalogue Number: 110034355
• Device Lot Number: 835AAE2507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 06/25/2020
• Supplement Dates FDA Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1