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	Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377)
Date of Event	04/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: refobacin bc r 1x40 us; item# 110034355; lot# 805bak0203.Femoral component option size f right; item# 00596401652; lot# 63868359.Stemmed nonaugmentable tibial component option cr/ps/lps size 7 for cemented use only; item# 00598605701; lot# 64021336.Articular surface size ef 12 mm height "use with plate 7; item# 00596405112; lot# 63054214 all poly petella standard cemented size 35 mm diameter 9.0 mm thickness; item# 00597206535; lot# 63932368.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 the patient underwent an initial right total knee arthroplasty.Subsequently, four years after the initial procedure, the patient was revised due to subsidence of the tibial implant.During the revision it was noted that the tibial implant had subsided into extension varus, severe synovitis, and osteolysis.The femoral and tibial components 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).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.A review of the device manufacturing records of the semi finished product batch 805ba 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 increased pain, varus deformity, workup shows complete failure of tibial baseplate with subsidence into varus.Pre-op diagnosis: aseptic failure, right knee.General anesthesia with adductor canal block, ebl 400ml.Patellar component did not need to be revised.50ml of bloody fluid removed.Severe polyethylene synovitis no sign of infection.Tibial component subsided into extension and varus.Femoral component well fixed and well aligned, cement removed from femur, femur explanted.Tibial component removed, osteolysis in the bone below the cement noted.Trial implants placed, excellent alignment, balance, and tracking.Final components placed, wound thoroughly irrigated, wound closed in layers, wound vac placed.Patient to recovery in satisfactory condition.No intraoperative complication noted.Based on the medical records received, 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, 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 26903 ; FR 26903
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21713765
• Report Number: 3006946279-2025-00032
• Device Sequence Number: 9952513
• Product Code: MBB
• UDI-Device Identifier: 00880304990197
• UDI-Public: (01)00880304990197(17)210131(10)805BAK0203
• 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: 2019
• Device Explanted 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): 07/17/2025

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: 01/31/2021
• Device Catalogue Number: 110034355
• Device Lot Number: 805BAK0203
• 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: 06/30/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2018
• 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: Male
• Patient Weight: 82 KG