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

Catalog Number	110035368
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 1 year and 7 months post initial implantation, the patient underwent a revision surgery due to femoral implant loosening.Due diligence is in progress for this complaint; no further additional information or product has been received at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: associated medical devices: femur cemented cruciate retaining (cr) narrow left size 5; item#: 42502005801; lot#: 65594368.Tibia cemented 5 degree stemmed left size c; item#: 42532006401; lot#: 65850326.Stem extension tapered cemented 14 mm diameter +30 mm length; item#: 42557000114; lot#: 65996857.All poly petella standard cemented size 29 mm diameter 8.0 mm thickness; item#: 00597206529; lot#: 65840350.Articular surface medial congruent (mc) left 13 mm height use with tibia sizes c-d/cr femur sizes 4-5; item#: 42512100313; lot#: 65580509.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 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, 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.The reported products were reviewed for compatibility with the cement no issues noted.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 the complaint trending process.Radiographs were provided and reviewed by a radiologist.The review identified a single lateral x-ray view of the knee dated six weeks before the revision surgery was performed.Cemented total knee arthroplasty components are present.Sagittal alignment of components is standard as visualized on the lateral projection.The patella is low-lying.As visualized on the lateral projection, there is a paucity of cement in knee society femoral zones 1 and 2 and tibial zones 3a and 4a.Radiolucent lines consistent with artifacts are present at both femoral and tibial bone-soft tissue, metal-soft tissue, metal-bone and cement-bone interfaces.These artifacts limit assessment for radiolucencies due to prosthesis component loosening.Based on the available lateral radiograph, prosthetic component loosening can neither be confirmed or excluded.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.

• Brand Name: BIOMET 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: 21730269
• Report Number: 3006946279-2025-00040
• Device Sequence Number: 19860733
• Product Code: LOD
• UDI-Device Identifier: 00887868214578
• UDI-Public: (01)00887868214578(17)251231(10)AW02AB0602
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K172408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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): 08/14/2025

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: 12/31/2025
• Device Catalogue Number: 110035368
• Device Lot Number: AW02AB0602
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 54 KG