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

Model Number N/A

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the cement used for the case started to go hard at 5 minutes.It was during the impaction of the femur that it started going off.The patient was in a couple degrees of extension so even though the femoral component did not fully seat it ended up in 2 degrees of flexion which the surgeon was satisfied with.

Manufacturer Narrative

(b)(4).This follow-up report is being filled to relay additional information.The following sections were updated: b5, d1, d4, d5, e1, g1-2, g4, h2, h3, h4, h6, h10.The product was not returned and could not be analyzed.Ttherefore,, the reported event could not be fonfirmed.The review of the device manufacturing quality record indicates that (b)(4) products optipac-s 60 refobacin plus bone cement, reference 4721502084-1, lot number a703a07285 were manufactured on 24 may 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.2 similar complaints (including the current complaint) have been recorded for optipac, reference 4721502084-1, batch a703a07285, within one 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 has reported that the cement used for the case started to go hard at 5 minutes.It was during the impaction of the femur that it started going off.The patient was in a couple degrees of extension so even though the femoral component did not fully seat it ended up in 2 degrees of flexion which the surgeon was satisfied with.No adverse patient consequences were reported.

• Brand Name: OPTIPAC-S 60 REFOBACIN PLUS BO NE 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: 8292446
• MDR Text Key: 134591504
• Report Number: 3006946279-2019-00080
• Device Sequence Number: 1
• Product Code: MBB
• 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
• Report Date: 10/23/2019

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: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 47215020841
• Device Lot Number: A703A07285
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2018
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 09/25/2019
• Supplement Dates FDA Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1