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 Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: refobacin bc r 1x40 us; item# 110034355; lot# k1905z22ba; refobacin bc r 1x40 us; item# 110034355; lot# k1905z22ba; femur cemented standard right size 7; item# 42504606202; lot# 64838116; stem extension tapered cemented 14 mm diameter +75 mm length; item# 42560007514; lot# 64853522; femoral distal augment cemented size 7, 7+ 5 mm thickness; item# 42556606205; lot# 64817473; tibia fixed cemented right size c stem extension use required; item# 42542006402; lot# 64679144; articular surface fixed bearing constrained posterior stabilized (cps) right 10 mm height use with tibia sizes c-d / ps femur sizes 6-9; item# 42522600510; lot# 64046555; stem extension tapered cemented 14 mm diameter +75 mm length; item# 42560007514; lot# 64853522; unknown mesh; item# unknown; 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 at the two-year follow-up following an initial right total knee arthroplasty, the patient reported experiencing pain.This pain has persisted through to the most recent follow-up, conducted four years post the initial procedure.All radiographic imaging revealed no significant findings, and all implanted components remain implanted.Attempts have been made and no further additional event information has been provided 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 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.Medical records were provided and reviewed by a health care professional.The review identified right hip abscess requiring revision of ipsilateral tha and iv abx two months prior to onset as contributing factor to the event.Additionally, extensive scar tissue from pervious surgery and patella fracture could be contributing to pain 2 years post according to patient's surgeon.Implants on x-ray look good and well fixed.X-ray review identified implants in good position and alignment without evidence of failure, loosening or fracture.Patient is status post complex right revision total hip arthroplasty with a longstanding history of right hip pathology, including multiple surgical interventions.She continues to experience chronic right hip pain, weakness, and instability, which significantly limits her ability to safely ambulate without assistive support.Based on the available medical records, 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: 22086064
• Report Number: 3006946279-2025-00062
• Device Sequence Number: 7885899
• Product Code: MBB
• UDI-Device Identifier: 00880304990197
• UDI-Public: (01)00880304990197(17)230430(10)K1905Z22BA
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K171540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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 Expiration Date: 04/30/2023
• Device Catalogue Number: 110034355
• Device Lot Number: K1905Z22BA
• 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: 05/01/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2020
• 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: 67 KG
• Patient Race: White