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

Catalog Number 4721502084-3

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).The device will not be returned to the manufacturer.Therefore it will not be analyzed.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 bone cement of the optipac hardened too quickly.No adverse health consequences were reported as the result of the event.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The product analysis can't be performed as the product was not returned.A retain sample of batch a927a02665 has been tested in the laboratory under standardized conditions (23°c; rel.Humid >=40 %).No unusual behavior during mixing, handling or setting.The reported behavior of the cement cannot be reproduced.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.A complaint extract was done regarding cement paste too short setting time: 4 complaints (7 products), this one included, have been recorded on optipac 60 refobacin plus bone cement-3, reference (b)(4), from (b)(6) 2017 to (b)(6) 2020.2 complaints (4 products), this one included, have been recorded on optipac 60 refobacin plus bone cement-3, reference (b)(4), batch a927a02665.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.

Event Description

It was reported that the bone cement of the optipac hardened too quickly.No adverse health consequences were reported as the result ofthe event.

• Brand Name: OPTIPAC 60 REFOBACIN PLUS BONE CEMENT
• 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: 10217642
• MDR Text Key: 197926395
• Report Number: 3006946279-2020-00117
• 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
• Report Date: 11/25/2020

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: 01/31/2021
• Device Catalogue Number: 4721502084-3
• Device Lot Number: A927A02665
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2020
• Initial Date FDA Received: 07/01/2020
• Supplement Dates Manufacturer Received: 11/19/2020
• Supplement Dates FDA Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1