MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. BIOMET BONE CMENT R 1X40 JP; BIOMET BONE CEMENT

Model Number N/A

Device Problem Chemical Problem (2893)

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

Event Date 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source¿ foreign ¿ japan.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that when the surgeon mixed the bone cement, the monomer and polymer did not mix.The consistency remained powdery after waiting more than 3 minutes.The product could not be used.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

Visual examination of the returned product and provided pictures identified the mixing is heterogeneous and has lumps.A retain sample of batch x20aaf1707 has been tested in the laboratory under standardized conditions (23°c; rel.Humid >=40 %).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.Reported event is not related to medical condition.Review of medical record is not applicable.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.

Event Description

No further event information available at the time of this report.

• Brand Name: BIOMET BONE CMENT R 1X40 JP
• Type of Device: BIOMET 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: 16426187
• MDR Text Key: 310168218
• Report Number: 3006946279-2023-00008
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 00887868358487
• UDI-Public: (01)00887868358487(17)240131(10)X20AAF1707
• 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,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 110035372
• Device Lot Number: X20AAF1707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2022
• 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 Outcome(s): Other
• Patient Sex: Prefer Not To Disclose