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 Code	Aseptic loosening (4883)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial right knee arthroplasty.Subsequently, approximately seventeen months post-implantation, the patient underwent revision surgery due to loosening of the femoral component.Due diligence is in progress for this complaint; no further information has been received at the time of this report.
Additional Manufacturer Narrative
(b)(4) d10 - associated medical devices: refobacin bc r 1x40 us; item# 110034355; lot# av10cg2602 femur cemented cruciate retaining (cr) standard right size 7; item# 42502606202; lot# 66816774 all poly patella cemented 32 mm diameter; item# 42540000032; lot# 66514568 tibia cemented 5 degree stemmed right size e; item# 42532007102; lot# 66435064 articular surface medial congruent (mc) right 10 mm height use with tibia sizes e-f/cr femur sizes 6-7; item# 42522100710; lot# 66567077 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.

• 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 26903 ; FR 26903
• 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 ; +1(574)526-0384
• MDR Report Key: 50715458
• Report Number: 3006946279-2026-00046
• Device Sequence Number: 10696302
• Product Code: LOD
• UDI-Device Identifier: 00887868214578
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K172408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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 Catalogue Number: 110035368
• Device Lot Number: AV25DH0102
• 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: 08/21/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2024
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 197 LB