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

Catalog Number	110034355
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient had a right total elbow arthroplasty followed by a revision due to pain and ulnar loosening.Subsequently, underwent a second revision due to loosening of the ulnar and humeral implants.A competitor, custom made, ulnar implant and a zb humeral implant were placed.Approximately 5 years and 1 months post-implantation.No additional information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: item name: refobacin bc r 1x40 us; item number: 110034355; lot: unknown.Item name: humeral screw kit 2 humeral screws; item number: 00840009000; lot: 65933938.Item name: articulation kit size 4 1 axle pin, 1 humeral bearing a, 2 ulnar bearings b sterile product do not resterilize; item number: 00840009400; lot: 65385845.Item name: ulnar component plasma sprayed size 5 115 mm length right for cemented use only; item number: 00840002511; lot: 63028261.Item name: humeral component plasma sprayed size 4 100 mm length for cemented use only; item number: 00840004410; lot: 64290038.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
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, g1-2, g3, g6, h2, h3, h6, h10, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records batch confirmed no abnormalities or deviations.A review of the raw material certificate batch confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint history identified additional similar complaints for the reported item and additional similar complaints for the reported part and lot combination.Medical records were provided related to the linked complaint and reviewed by a health care professional.Review of the available records identified the following: "the patient got a revision of the same elbow yesterday.A custom onkos ulnar component and the zimmer biomet srs distal humeral component were utilized.Both components were loose when the surgeon got into the elbow.Additional notes: oncologist doctor, likely a case with a patient with preexisting conditions/comorbidities.¿ cement allergy was identified as a contributing factor to the event.A definitive root cause cannot be determined.If any further information is found that 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: 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): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21419669
• Report Number: 3006946279-2025-00021
• Device Sequence Number: 7987058
• Product Code: MBB
• UDI-Device Identifier: 00880304990197
• UDI-Public: (01)00880304990197(17)210731(10)835AAE2507
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K150850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 110034355
• Device Lot Number: 835AAE2507
• 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: 01/31/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female