MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN PLUS BONE CEM 40 -3; BONE CEMENT, ANTIBIOTIC

Catalog Number 3020830401-3

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Concomitant medical products bowl with spatula 20pk; ref: 4120 ; batch: unknown.The device was not returned to the manufacturer.Therefore it could not be analyzed.The review of the device manufacturing quality record indicate that 6685 products designation refobacin plus bone cement 40-3, reference 3020830401-3, batch 833fae0802 were manufactured on november 21, 2018.The device manufacturing quality record of 6429586 indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.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 cement hardened too fast when they added the powder and there was a very unpleasant smell, different from the usual.No adverse events have been reported as a result of the malfunction.

Event Description

It was reported that cement hardened too fast when they added the powder and there was a very unpleasant smell, different from the usual.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).G3 - report source, foreign - event occurred in spain.This follow-up report is being filled to relay additional information.The device will not be returned to the manufacturer.Therefore it will not be analyzed.Reserve sample from the same lot was tested under standardized conditions.The product did not show any unusual behavior during mixing, handling or setting.The reported behavior of the cement could not be reproduced.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.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 PLUS BONE CEM 40 -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
• MDR Report Key: 9236903
• MDR Text Key: 208599476
• Report Number: 3006946279-2019-00435
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 04040029922651
• UDI-Public: (01)04040029922651
• Combination Product (y/n): N
• PMA/PMN Number: K171540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

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: 3020830401-3
• Device Lot Number: 833FAE0802
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 10/03/2019
• Supplement Dates FDA Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1