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

Catalog Number 4712500398-3

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The device manufacturing quality record could not been reviewed as the lot number was not correct.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 monomer and polymer could not be mixed properly.The cement had become very tough after only a few seconds during mixing.There were powder residues in the lower part of the cartridge, that have not combined with the liquid.Another optipac 60 refobacin bone cement r was used to complete the surgery.No impact to the patient has been reported as the result of the malfunction.

Event Description

It was reported that monomer and polymer could not be mixed properly.The cement had become very tough after only a few seconds during mixing.There were powder residues in the lower part of the cartidge, that have not combined with the liquid.Another optipac 60 rrfobacin bone cement r was used to complete the surgery.No impact to the patient has been reported as the result of the malfunction.

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 902aa02660 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 could not be reproduced.Therefore, the reported event could not be confirmed.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.2 complaints (2 products), this one included, have been recorded on optipac 80 refobacin bone cement r, reference 4712500398-3, batch 902aa02660 regarding mixing issue.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 80 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: 9882038
• MDR Text Key: 186755811
• Report Number: 3006946279-2020-00035
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

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: 12/31/2020
• Device Catalogue Number: 4712500398-3
• Device Lot Number: 902AA02660
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: 09/22/2020
• Supplement Dates FDA Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1