MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 40 REFOBACIN PLUS BONE 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 03/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The device will not be returned to the manufacturer.Therefore, it will not be analyzed.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported that the cements did not fix the implant, three consecutive times in the same surgery.The cement did not make the mechanically anchor and the implant got out of the cement.It was necessaire to remove the cement from the patient.A cement from competitor was used.For each open cement, there was a delay of approximately 15 minutes.No patient adverse consequence was reported.

Manufacturer Narrative

(b)(4).This follow-up report is being filled to relay additional information.The reported event could not be confirmed : the device was not be returned to the manufacturer.Therefore it could 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 refobacine plus bone cement-3, reference (b)(4), batch 807aa07130 were manufactured on 16th march 2018.No non-conformity was found related to the event.Also, the review of the sterilization certificate indicates that the products were sterilized according to the specification.2 other similar complaints have been recorded for optipac 40 refobacin plus bone cement-3, batch 807aa07130 within one year.With the available information, the exact root cause of the event could not be determined.A letter conveying the investigation results 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 fix the implant, three consecutive times in the same surgery.The cement didn¿t make the mechanically anchor and the implant got out of the cement.It was necessary to remove the cement from the patient.A cement from competitor was used.For each open cement, there was a delay of approximately 15 minutes.No adverse events has been reported.

• Brand Name: OPTIPAC 40 REFOBACIN PLUS BONE 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: 8491210
• MDR Text Key: 141187942
• Report Number: 3006946279-2019-00211
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 04040029922354
• UDI-Public: (01)04040029922354
• Combination Product (y/n): N
• PMA/PMN Number: K171540
• 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: 03/21/2019
• Initial Date FDA Received: 04/08/2019
• Supplement Dates Manufacturer Received: 04/15/2019; 09/06/2019
• Supplement Dates FDA Received: 05/03/2019; 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1