MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 80 REFOBACIN BONE CEMENT R-3; BONE CEMENT, ANTIBIOTIC

Catalog Number 4712500398-3

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned to the manufacturer.Therefore it could not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.Investigation results concluded that the product is conform and the root cause is undetermined.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 has been reported that the monomer fluid wasn't injected into the cartridge after having pressed the blue brackets.

Event Description

It has been reported that the monomer fluid wasn't injected into the cartridge after having pressed the blue brackets.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.Complaint sample was evaluated and the reported event was confirmed.No product non-conformity was identified.Product analysis showed that the most probable root cause is a handling error.Investigation results concluded that the reported event was likely due to an handling error.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: OPTIPAC 80 REFOBACIN BONE CEMENT R-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: 8357458
• MDR Text Key: 136786383
• Report Number: 3006946279-2019-00101
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 04040029922385
• UDI-Public: (01)04040029922385
• 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
• Type of Report: Initial,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 4712500398-3
• Device Lot Number: 712BA07300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1