MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. REFOBACIN BC R 1X40 US; BONE CEMENT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930); Pain (1994); Fungal Infection (2419); Radiolucent Lines (4848); Joint effusion (4849)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient, who has undergone multiple surgeries related to a left elbow arthroplasty, is currently experiencing complications that include persistent elbow effusion, pain, lucency, and chronic infections.Despite long-term antibiotic treatment, the elbow remains "useless," prompting the need for further revision surgery.Due diligence is in progress for this event; to date no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.D10: item name # pin/bushing replacement kit extra small for use with extra small humeral implants: 32-8105-27-04,06; item number # 32810502701; lot# 65475544.Item name # interchangeable humeral assembly for cemented use only extra small; item number # 32810502706; lot# 64631859.Item name# unk threaded k-wires x 3; item number # unknown; lot# unknown.Item name # interchangeable ulnar assembly plasma sprayed extra small left 3 inch length; item number # 32810504301; lot # 64662236.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported a patient had an initial left total elbow arthroplasty.The patient has an extensive history of operations, which include an ulnar nerve transposition, a revision of a humeral component due to loosening, and an i&d with a bushing exchange due to an evacuation of a hematoma and klebsiella and staph epidermidis.Subsequently, following the latest revision, completed the course of antibiotics for the bacterial infection and then developed candida lusitaniae and was placed on long-term anti-fungal treatment.Radiographic imaging displayed lucency of the humeral component and has continued with symptoms of pain.An aspiration displayed positive results of pseudomonas and clavispora and is undergoing another course of antibiotics.The patient is under the care of infectious disease for the chronic infections, and a revision is pending the review of the material composition of the implants.

• Brand Name: REFOBACIN BC R 1X40 US
• Common Device Name: BONE CEMENT
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex
• Manufacturer (Section G): .; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 21110141
• Report Number: 3006946279-2025-00002
• Device Sequence Number: 20752937
• Product Code: LOD
• UDI-Device Identifier: 00880304990197
• UDI-Public: (01)00880304990197(17)250430(10)AX18CB0304
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 110034355
• Device Lot Number: AX18CB0304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 59 KG