MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 60 REFOBACIN BONE CEMENT R-3; ORTHOPAEDIC CEMENT, MEDICATED

Catalog Number 4711500396-3

Device Problem Chemical Problem (2893)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).The device manufacturing quality record indicates that the released product met all requirements to perform as intended.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 the cement of the optipac has not the correct consistency during surgery.The product has not been used and it has been discarded.There was no patient involvement.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections have been updated : b4, g4, g7, e1, h2, h6, h10.An analysis of a product with the same reference and batch number has been realized.The product analysis shows that the product is an optipac and the cement is compliant with the specifications.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 the cement of the optipac has not the correct consistency during surgery.The product has not been used and it has been discarded.There was no patient involvement.

Event Description

It was reported that the cement of the optipac has not the correct consistency during surgery.The product has not been used and it has been discarded.There was no patient involvement.No known adverse event was reported.

Manufacturer Narrative

This is a combination product: (b)(4).8 complaints (9 products), this one included, have been recorded on optipac 60 refobacin bone cement r-3, reference 4711500396-3, from sep 22, 2017 to mar 23, 2021.1 complaint (2 products), this one included, has been recorded on optipac 60 refobacin bone cement r-3, reference 4711500396-3, batch a938a05405 since ever.According to available data, root cause of the event was unable to be determined.However, there is no evidence that the event is related to the product.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 60 REFOBACIN BONE CEMENT R-3
• Type of Device: ORTHOPAEDIC CEMENT, MEDICATED
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 10676255
• MDR Text Key: 220942198
• Report Number: 3006946279-2020-00204
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• 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: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 4711500396-3
• Device Lot Number: A938A05405
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1