MAUDE Adverse Event Report: Biomet France S.A.R.L. BIOMET BC R 1X40 US; Bone Cement

Catalog Number	110035368
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial right total knee arthroplasty and was discharged from physical therapy three days later with a range of motion of 0¿121 degrees.Approximately two weeks after discharge from physical therapy, the patient experienced a sudden onset of severe knee pain upon waking up.The patient continues to experience pain and decreased range of motion.The patient has undergone two additional courses of physical therapy outside of the initial post-operative therapy course.The event is ongoing.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) d10 - associated medical devices: articular surface fixed bearing ultracongruent (uc) right 12 mm height; item# 42522200412; lot# 67620080 tibia cemented 5 degree stemmed right size c; item# 42532006402; lot# 67017716 femur cemented cruciate retaining (cr) standard right size 5; item# 42502605802; lot# 67351018 all poly patella cemented 29 mm diameter; item# 42540000029; lot# 67535801 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: 50519229
• Report Number: 3006946279-2026-00042
• Device Sequence Number: 9375684
• Product Code: LOD
• UDI-Device Identifier: 00887868214578
• 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: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 110035368
• Device Lot Number: AU14BE1202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2025
• 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: 157 LB