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

Catalog Number	110034355
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Loss of Range of Motion (2032); Rash (2033); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial left total knee arthroplasty.Subsequently, the patient reported that since surgery has been suffering with ongoing pain, redness, swelling, rash, decreased range of motion, stiffness, and tightness of knee.The patient has consulted an immunologist who is testing her for allergies to the components and bone cement.Attempts have been made, and all additional information received has been included in this report.
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products: femur cemented cruciate retaining (cr) standard nitrided left size 5; item number#: 42572605801; lot number#: 65588780.Articular surface medial congruent (mc) left 12 mm height use with tibia sizes c-d/cr femur sizes 4-5; item number#: 42512100312; lot number#: 65594820.Tibia cemented 5 degree stemmed left size d; item number#: 42532006701; lot number#: 66891502.All poly patella cemented 32 mm diameter; item number#: 42540000032; lot number#: 67037346.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.
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, d2a, g3, g6, h2, h3, h6, h11.No product was returned or pictures provided; a product evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Medical records were provided and reviewed by a health care professional.The review identified an allergy to contact metal agent as contributing factor of event.Patient underwent continual pain starting shortly after surgery, that is worsening with some rash, heat, very limited range of motion, stiffness and swelling.Sever tightness also noticed, as if a tight cast is around the knee.Additionally, contributing condition was noticed: osteoarthritis.Mild injury where knee popped while climbing stairs resulting in pain and swelling.Mri taken and physical therapy prescribed for two months.Prognosis arthritis.No issues after therapy.A definitive root cause could not 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: REFOBACIN BC R 1X40 US
• Common Device Name: BONE CEMENT, ANTIBIOTIC
• 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23013709
• Report Number: 3006946279-2025-00104
• Device Sequence Number: 15908888
• Product Code: MBB
• UDI-Device Identifier: 00880304990197
• UDI-Public: (01)00880304990197(17)270131(10)C0104V07BA
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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 Catalogue Number: 110034355
• Device Lot Number: C0104V07BA
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• 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 H11 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 57 KG