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 Problems Material Discolored (1170); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 10/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign: event occurred in (b)(6).The device was not returned to the manufacturer.Therefore it could not be analyzed.The review of the device manufacturing quality record indicates that 1 951 products optipac 80 refobacin bone cement r-3 reference (b)(4), batch 845aa05610 were manufactured on 21 february 2019.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.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 patient underwent revision surgery post three months of the implant surgery due to loosening of the implant.During the revision surgery the cement was found as white in color instead of green.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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.No similar complaint was received regarding optipac 80 refobacin bone cement r-3, reference (b)(4) within a year.With the available information, the exact root cause of the event could not be determined.A summary of the investigation was sent to the complainant conveying zimmer biomet conclusions 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 patient underwent revision surgery post three months of the implant surgery due to loosening of the implant.During the revision surgery the cement was found as white in color instead of green.

• 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: 9244558
• MDR Text Key: 173482707
• Report Number: 3006946279-2019-00452
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 04040029922385
• UDI-Public: (01)04040029922385
• 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
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 4712500398-3
• Device Lot Number: 845AA05610
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention