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); Synovitis (2094)
Date of Event	08/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial right total knee arthroplasty.Subsequently, approximately seven months post implantation, the patient was revised due to aseptic loosening.During the revision, severe polyethylene synovitis and grossly loose and subsided tibia were noted.The femur was noted to be well fixed however, revised to ensure balance of the knee.Patella was intact and not resurfaced.Femur, tibia, and articular surface were revised without complications.Attempts have been made and no further event information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4) d10 - associated medical devices: refobacin bc r 1x40 us; item# 110034355; lot# l0704y09ba, stemmed nonaugmentable tibial component option cr/ps/lps size 4 for cemented use only; item# 00598603702; lot# j6642324, femoral component option for cemented use only size e right; item# 00576401552; lot# 65011105, all poly petella standard cemented size 29 mm diameter 8.0 mm thickness; item# 00597206529; lot# 64774852, articular surface size ef 10 mm height "use with plate 3; item# 00596403210; lot# 63928161.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 information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h10, 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.Complaints are monitored per complaint trending process.Medical records were provided and reviewed by a health care professional.The review identified no contributing factors of the event.Review of the revision operative report identified that patient had an aseptic loosing and progressive varus deformity, pain.Infection workup negative.Severe polyethylene synovitis was noted.Tibia was grossly loose and subsiding into varus position.Femoral component was well fixed but revised to balance the knee correctly.Patella component was intact and did not need to be resurfaced.No intraoperative complications were noted.Based on the available information, 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 is available at the time of this report.

• 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: 21718455
• Report Number: 3006946279-2025-00036
• Device Sequence Number: 3928997
• Product Code: LOD
• UDI-Device Identifier: 00880304990197
• UDI-Public: (01)00880304990197(17)240229(10)L0704Y09BA
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 110034355
• Device Lot Number: L0704Y09BA
• 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: 06/12/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2021
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 60 KG