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

Catalog Number 4710500394-3

Device Problem Chemical Problem (2893)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

This is a combination product (b)(4).Report source, foreign and health professional - event occurred in (b)(6).List of associated products : item number 405940 item name comp rvs hmrltrl 44std-36std 4std-36std lot # unknown.Item number 405907 item name 25mm compr rvs taper adapt trl lot # unknown.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 by the nurse an optipac 40g was mixed as usual, with all surgical theatre temperatures same as in the past on average 16 degrees.2min after the mixing, the staff tried to press the cement paste out of the nozzle and it was very sticky and only became workable at about 5min.The doctor complained about the cement consistency.The cement paste took about 15-16min to set.No patient health consequences or impact has been reported.

Event Description

It was reported by the nurse that an optipac 40g was mixed as usual, with all surgical theatre temperatures same as in the past on average 16 degrees.2 minutes after the mixing, the staff tried to press the cement paste out of the nozzle and it was very sticky and only became workable at about 5 minutes.The doctor complained about the cement consistency.The cement paste took about 15-16 minutes to set.No patient health consequences or impact has been reported.

Manufacturer Narrative

(b)(4).This follow-up is to relay additional information.The device manufacturing quality record can't be performed since the batch number was not communicated.6 complaints on cement paste consistency was recorded on the reference from oct 01, 2018 to dec 28, 2021.The complaint history, regarding the batch number, can't be performed as it was not communicated.According to available data, root cause of the event was unable to 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.

• Brand Name: OPTIPAC 40 REFOBACIN BONE CEMENT R-3
• Type of Device: ORTHOPAEDIC CEMENT, MEDICATED
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12688404
• MDR Text Key: 280574688
• Report Number: 3006946279-2021-00185
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/03/2022

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 Catalogue Number: 4710500394-3
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/01/2021
• Initial Date FDA Received: 10/25/2021
• Supplement Dates Manufacturer Received: 12/08/2021
• Supplement Dates FDA Received: 01/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1