MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 80 REFOB BONE CMT R-3; BONE CEMENT

Model Number N/A

Device Problem Improper Chemical Reaction (2952)

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

Event Date 03/22/2023

Event Type  malfunction  

Event Description

It was reported that during surgery the cement paste set too fast.The cement was taken from the refrigerator about (10) minutes before the start of the surgery.The surgeon began using the cement approximately (4) minutes after the start of mixing.Insertion of the implant was about (5) minutes from the start of mixing.The cement then hardened in about (7) minutes.No impact on a patient.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).G2 ¿ foreign ¿ "japan".No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A retain sample of batch has been tested in the laboratory under standardized conditions.No unusual behavior during mixing, handling or setting.The reported behavior of the cement cannot be reproduced.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Device used for treatment.Medical records were not provided.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OPTIPAC 80 REFOB BONE CMT R-3
• Type of Device: BONE CEMENT
• 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: 17209551
• MDR Text Key: 318203902
• Report Number: 3006946279-2023-00055
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 04040029922385
• UDI-Public: (01)04040029922385(17)230630(10)AY47CI1605
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 4712500398-3
• Device Lot Number: AY47CI1605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose