MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC-S 60 REFOBACIN BONE CEMENT R; BONE CEMENT, ANTIBIOTIC

Model Number N/A

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that monomer was not entering.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following section has been updated : b5, d1, e1, g1-2, g4, h2, h3, h6, h10.The reported event could not be confirmed.The device was not returned to the manufacturer.Therefore it could not be analyzed.The review of the device manufacturing quality record indicates that (b)(4) products optipac-s 60 refobacin bone cement r, reference 4711500396-1, lot number a714b06385 were manufactured on 18 april 2017.The device manufacturing quality record 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.1 complaint has been recorded for optipac-s 60 refobacin bone cement r, reference 4711500396-1, batch a714b06385 on the reported event within one year.With the available information, the exact root cause of the event could not be determined.An investigation has been performed, consisting of a documentary review.The documentary review showed that product was manufactured according to the pre-defined specifications of biomet france.The product analysis can't be performed as the product was not returned.According to available data, the exact root cause can¿t 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.

Event Description

It was reported that monomer was not entering.No adverse event has been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following section has been updated : e1, h2, h3, h6, h10.The involved product was received and analyzed.During the product analysis, it was noticed that the returned product was an optipac with two pouches.The left pouch was partially empty and the other was totally empty.Both of the left and right cylinder cannula were obstructed.Therefore, the product analysis permitted to confirm the reported event.The review of the device manufacturing quality record indicates that 1912 products optipac-s 60 refobacin bone cement r, reference (b)(4), lot number a714b06385 were manufactured on 18 april 2017.The device manufacturing quality record 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.1 complaint has been recorded for optipac-s 60 refobacin bone cement r, reference (b)(4), batch a714b06385 on the reported event within one year.According to available data, the exact root cause 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.

Event Description

It was reported that monomer was not entering.No adverse event has been reported as a result of the malfunction.

• Brand Name: OPTIPAC-S 60 REFOBACIN BONE CEMENT R
• 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: 8329505
• MDR Text Key: 138557475
• Report Number: 3006946279-2019-00113
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 03599870112229
• UDI-Public: (01)03599870112229
• Combination Product (y/n): N
• PMA/PMN Number: K150850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 4711500396-1
• Device Lot Number: A714B06385
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1