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

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item name# lps-flex gsf opt sz d-r; item number# 00-5764-014-52; lot# 64469963.Item name# lps-flex fxd mld cd/3-4 12mm; item number# 00-5964-030-12; lot# 64227007.Item name# all poly pat comp 32dia; item number# 00-5972-065-32; lot# 64774873.Item name# option st tib plt size 4; item number# 00-5986-037-02; lot# j6730652.Item name# unknown bone cement plugs; item number# unknown bone cement plugs lot# unknown.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 a patient underwent a right total knee arthroplasty.Subsequently, the patient was revised on approximately four years later due to pain, swelling, stiffness, and instability.During the revision, the tibial component was found grossly loose.Medial osteolysis was noted at the tibial surface as well.The patella and femur were found well fixed and left intact.All tibial components were revised without complications.Attempts have been made and all additional information received has been included in this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D-10 refobacin bc r 1x40 us catalog#: 110034355.Lot#: unknown.No product was returned or pictures provided; a product evaluation could not be performed.A review of the device manufacturing records could not be performed due to missing lot number.Review of the complaint history identified additional similar complaints for the reported item.However, due to the lack of the lot number/s, an additional lot search could not be performed.Medical records were provided and reviewed by a health care professional.The review identified patient presented with pain and swelling, x-rays showed medial osteolysis under the tibia, bone scan shows reuptake of the tibial component, workup negative for infection.Tibia found grossly loose.Tibial surface revealed medial osteolysis.Femur and patella revealed excellent fixation, left intact.Tibial components replaced without complication.A definitive root cause could not be determined.However, there is contributing factors of event: highly active patient.Patient takes bisphosphonates for osteopenia which alters bone metabolism.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: REFOBACIN 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 20829816
• Report Number: 3006946279-2024-00086
• Device Sequence Number: 4159451
• Product Code: MBB
• UDI-Device Identifier: 00880304990197
• UDI-Public: (01)00880304990197
• 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: 2020
• Device Explanted Year: 2024
• 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): 01/31/2025

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 Model Number: N/A
• Device Catalogue Number: 110034355
• Device Lot Number: UNKNOWN
• 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: 11/19/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: White