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

Model Number N/A

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (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 cements did not fix the implant, three consecutive times in the same surgery.

Event Description

It has been reported that the cements did not fix the implant, three consecutive times in the same surgery.For each open cement, there was a delay of approximately 15 minutes, which makes a total delay of 45 minutes.None of these 3 cements was implanted, and a 4th cement from a competence brand was used to complete the surgery.The cement storage temperature was 20°c, the cement storage humidity was 50%, the operating room temperature was 19°c.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The investigation is in progress.Once the investigation will be performed, a supplemental will be sent.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.

Manufacturer Narrative

(b)(4).This follow-up report is being filled to relay additional information.The event was not confirmed.The device will not be returned to the manufacturer.Therefore it will not be analyzed.Reserve sample from the same lot was tested under standardized conditions.The product did not show any unusual behavior during mixing, handling or setting.The reported behavior of the cement could not be reproduced.The review of the device manufacturing quality record indicates that (b)(4) products optipac 40 refobacin plus bone cement-3, reference (b)(4), batch 807aa07130 were manufactured on 16th march 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 other complaints have been recorded for optip 40 refobacin plus bone cement-3, batch 807aa07130 ((b)(4)) within one year.With the available information, the exact root cause of the event could not be determined.A summary of the investigation has been sent to the complainant.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 the cements did not anchor the implant, three consecutive times in the same surgery.For each open cement, there was a delay of approximately 15 minutes, which makes a total delay of 45 minutes.None of these 3 cements was implanted, and a fourth cement from a competence brand was used to complete the surgery.The three cements are investigated in the complaints (b)(4).No adverse events have been 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: 8503017
• MDR Text Key: 141587534
• Report Number: 3006946279-2019-00225
• 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: 09/09/2019

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: 08/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 4720502083-3
• Device Lot Number: 807AA07130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/11/2019
• Supplement Dates Manufacturer Received: 04/19/2019; 09/06/2019
• Supplement Dates FDA Received: 05/14/2019; 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1