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

Catalog Number	110034355
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent surgery for hematoma evacuation.A significant hematoma was noted, evacuated, and a drain was placed.No intraoperative complications were noted.Attempts have been made and all additional information received has been included in this report.
Additional Manufacturer Narrative
(b)(4).D10: item name: refobacin bc r 1x40 us; item number: 110034355; lot: x26aab1103.Item name: refobacin bc r 1x40 us; item number: 110034355; lot: x26aab1103.Item name: all poly petella standard cemented size 35 mm diameter 9.0 mm thickness; item number: 00597206535; lot:63932368.Item name: femur cemented plus right size 7+; item number: 42504606212; lot: 65092679.Item name: stem extension 3mm offset splined uncemented 14 mm diameter +135 mm length; item number: 42560313514; lot: 65347348.Item name: femoral distal augment cemented size 7, 7+ 10 mm thickness; item number: 42556606210; lot: 65755292.Item name: femoral posterior augment cemented size 7, 7+ 5 mm thickness; item number: 42556806205; lot: 65703519.Item name: tibia fixed cemented right size e stem extension use required; item number: 42542007102; lot: 65619850.Item name: tibial augment cemented half block right medial size ef 10 mm thickness; item number: 42555805410; lot: 64594695.Item name: stem extension straight splined uncemented 13 mm diameter +135 mm length; item number: 42560113513; lot: 64989092.Item name: articular surface fixed bearing constrained posterior stabilized (cps) right 10 mm height use with tibia sizes e-f / ps femur sizes 6-9; item number: 42522600710; lot: 64125950.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 product has not been evaluated, as it has been determined that the event is not related to the device.A hematoma is a mass of clotted blood that forms in a tissue, organ, or body space.A hematoma can be associated with pain, swelling, ecchymosis, serosanguinous or bloody drainage after a recent surgical procedure or trauma, and can predispose the patient to infection.The development of a postoperative hematoma can be correlated with the surgical procedure and perioperative anticoagulation therapy prescribed to prevent thrombus formation.Most hematomas resolve on their own, without surgical intervention, while some do not.Larger hematomas may need to be surgically evacuated in order to resolve.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.As this event covered shortly post revision and additional surgical intervention was conducted to resolve the hematoma, this event is associated with the procedure, implants were retained.The root cause of the reported event is not device-related.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: 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: 21695277
• Report Number: 3006946279-2025-00031
• Device Sequence Number: 9308087
• Product Code: LOD
• UDI-Device Identifier: 00880304990197
• UDI-Public: (01)00880304990197(17)250531(10)X26AAB1103
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K171540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: 05/31/2025
• Device Catalogue Number: 110034355
• Device Lot Number: X26AAB1103
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 82 KG