MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 40 REFOBACIN PLUS BONE CEMENT-3; BONE CEMENT ANTIBIOTIC

Catalog Number 4720502083-3

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.With the available information, the exact root cause of the event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

It has been reported that during surgery, cement hardened after 7 min.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following section has been updated : b5, d2, e1, g1-2, g4, g5, e1, h2, h6, h10.The product was not returned, however, a product analysis was performed on an another product of the same reference and batch retained at zimmer biomet facilities.This analysis show that the cement behavior was in compliance with the specifications.Also, the reported event is not confirmed.The review of the device manufacturing quality record indicates that 3095 products designation optipac 40 refobacin plus bone cement-3, reference 4720502083-3, lot number 817ba09230 were manufactured on 05 june 2018.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 complaints have been recorded for optipac 40 rrfobacin® plus bone cement r, batch 817ba09230 within one year.According to available data, the exact root cause can¿t be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

It has been reported that during surgery, cement hardened after 7 min.No known adverse event was reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following section has been updated : g4, h2, h6, h10.The product was not returned, however, a product analysis was performed on an another product of the same reference and batch retained at zimmer biomet facilities.This analysis show that the cement behavior was in compliance with the specifications.The reported event is not confirmed.The review of the device manufacturing quality record indicates that (b)(4) products designation optipac 40 refobacin plus bone cement-3, reference 4720502083-3, lot number 817ba09230 were manufactured on 05 june 2018.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.Only this complaint has been recorded on this issue for optipac 40 rrfobacin® plus bone cement r, batch 817ba09230 within one year.With the available information, the exact root cause of the event could not be determined.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 been reported that during surgery, cement hardened after 7 min.No known adverse event was reported.

• Brand Name: OPTIPAC 40 REFOBACIN PLUS BONE CEMENT-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: 8369401
• MDR Text Key: 137127523
• Report Number: 3006946279-2019-00154
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 04040029922354
• UDI-Public: (01)04040029922354
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2019

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: 11/30/2019
• Device Catalogue Number: 4720502083-3
• Device Lot Number: 817BA09230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2019
• Initial Date FDA Received: 02/26/2019
• Supplement Dates Manufacturer Received: 09/16/2019; 10/01/2019
• Supplement Dates FDA Received: 09/25/2019; 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1